Perennial Allergic RhinitisPhase 3NCT01033825
Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
A Phase 3 study testing Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg and Ciclesonide Aqueous Nasal Spray 200 mcg in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 6 sites in United States.
Trial summary
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg and Ciclesonide Aqueous Nasal Spray 200 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
- If any of the screening Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
- A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
- A demonstrated sensitivity to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to screening or performed at the Screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
- Subject, if female, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control.
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- An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- Abstinence.
Who cannot join
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 120 days prior to the Screening visit.
- Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
- History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening visit.
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- History of alcohol or drug abuse within 2 years preceding the Screening visit.
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.
- Expected use of any disallowed concomitant medications during the treatment period.
- Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
- Previous randomization in an intranasal ciclesonide HFA nasal aerosol study.
- Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
- Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
- Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
- Study participation by more than one subject from the same household.
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial: impaired hepatic function including alcohol related liver disease or cirrhosis; history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts; any systemic infection hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism; gastrointestinal disease; malignancy (excluding basal cell carcinoma); current neuropsychological condition with or without drug therapy
- Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Clinical Research Institute
Minneappolis, Minnesota, 55402
Central Texas Health Research
New Braunfels, Texas, 78130
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Sylvana Research
San Antonio, Texas, 78229
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subjects 12 Years and Older With Perennial Allergic Rhinitis
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of the effects of ciclesonide HFA nasal aerosol and ciclesonide AQ nasal spray on the HPA axis, when administered once daily to male and female subjects 12 years or older diagnosed with Perennial Allergic Rhinitis (PAR). The study consists of a screening period, a single blind run in period, a 6 week double blind treatment period including an active control segment, and a follow up period.
Placebo was used as the control during the double-blind treatment period for both delivery methods (HFA nasal aerosol and aqueous nasal spray)and for the study outcome analyses. There was also a positive control administered to a subset of these placebo subjects during the last 4 days of Week 6 (dexamethasone placebo or dexamethasone 6 mg). The active control was utilized to validate the assay sensitivity (ie, distinguish an effective from an ineffective drug) of this study, as dexamethasone is a known HPA axis suppressant, therefore this subset of placebo subjects was not included in the study outcome analyses.
This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg, HFA Nasal Aerosol placebo, Ciclesonide Aqueous Nasal Spray 200 mcg, AQ Nasal Spray Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide HFA Nasal Aerosol 320 mcgDrug
Ciclesonide HFA Nasal Aerosol 320 μg once daily
Ciclesonide HFA Nasal Aerosol 160 mcgDrug
Ciclesonide HFA Nasal Aerosol 160 μg once daily
HFA Nasal Aerosol placeboDrug
HFA Nasal Aerosol placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcgDrug
Also called Omnaris
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray PlaceboDrug
AQ Nasal Spray Placebo once daily
Placebo plus Dexamethasone HFADrug
Also called Decadron
Dexamethasone capsules 6 mg once daily
Placebo AQ plus Dexamethasone 6 mgDrug
Placebo AQ plus Dexamethasone 6 mcg capsules once daily
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 mcg | Experimental | Ciclesonide HFA Nasal Aerosol 320 mcg once daily Receives: Drug: Ciclesonide HFA Nasal Aerosol 320 mcg |
| Ciclesonide HFA Nasal Aerosol 160 mcg | Experimental | Ciclesonide HFA Nasal Aerosol 160 mcg once daily Receives: Drug: Ciclesonide HFA Nasal Aerosol 160 mcg |
| HFA Nasal Aerosol placebo | Placebo comparator | HFA Nasal Aerosol Placebo once daily Receives: Drug: HFA Nasal Aerosol placebo |
| Ciclesonide Aqueous Nasal Spray 200 mcg | Experimental | Ciclesonide Aqueous Nasal Spray 200 mcg once daily Receives: Drug: Ciclesonide Aqueous Nasal Spray 200 mcg |
| AQ Nasal Spray Placebo | Placebo comparator | AQ Nasal Spray Placebo once daily Receives: Drug: AQ Nasal Spray Placebo |
| Placebo HFA plus Dexamethasone 6 mcg | Active comparator | Placebo HFA plus Dexamethasone 6 mg once daily Receives: Drug: Placebo plus Dexamethasone HFA |
| Placebo AQ plus Dexamethasone 6 mg | Active comparator | Placebo AQ plus Dexamethasone 6 mg once daily Receives: Drug: Placebo AQ plus Dexamethasone 6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
Measured: Baseline
The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period
Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
Measured: week 6
Secondary outcomes (42)
Number of Subjects Experiencing Adverse Events (AEs)
Measured: Weeks 0-6
Percentage of Subjects Experiencing Adverse Events (AEs)
Measured: Weeks 0-6
Number of Subjects Experiencing Serious Adverse Events (SAEs).
Measured: Weeks 0-6
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
Measured: Weeks 0-6
Number of Subjects Who Discontinue Due to AEs
Measured: Weeks 0-6
Percentage of Subjects Who Discontinue Due to AEs
Measured: Weeks 0-6
Number of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Measured: Weeks 0-6
Percentage of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Measured: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
Measured: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
Measured: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
Measured: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
Measured: Weeks 0-6
Baseline Daily Subject-reported AM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported PM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported AM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported AM and PM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported PM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported AM and PM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:
0 = absent
- = mild
- = moderate
- = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual AM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual PM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual AM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual PM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.
Measured: Weeks 0-6
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).
Measured: Weeks 1-2, 2-4
Number of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Measured: Weeks 1-4
Percentage of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Measured: Weeks 1-4
Number of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.
Measured: Week 6
Percentage of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033825
- Sponsor's protocol ID
- 060-610
- Status last verified
- Jul 2012
- First submitted
- 16 Dec 2009
- Last updated
- 19 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subjects 12 Years and Older With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01033825
- Acronym / sponsor ID
- 060-610
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 19 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of the effects of ciclesonide HFA nasal aerosol and ciclesonide AQ nasal spray on the HPA axis, when administered once daily to male and female subjects 12 years or older diagnosed with Perennial Allergic Rhinitis (PAR). The study consists of a screening period, a single blind run in period, a 6 week double blind treatment period including an active control segment, and a follow up period.
Placebo was used as the control during the double-blind treatment period for both delivery methods (HFA nasal aerosol and aqueous nasal spray)and for the study outcome analyses. There was also a positive control administered to a subset of these placebo subjects during the last 4 days of Week 6 (dexamethasone placebo or dexamethasone 6 mg). The active control was utilized to validate the assay sensitivity (ie, distinguish an effective from an ineffective drug) of this study, as dexamethasone is a known HPA axis suppressant, therefore this subset of placebo subjects was not included in the study outcome analyses.
This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 mcg | Experimental | Drug: Ciclesonide HFA Nasal Aerosol 320 mcgCiclesonide HFA Nasal Aerosol 320 mcg once daily |
| Ciclesonide HFA Nasal Aerosol 160 mcg | Experimental | Drug: Ciclesonide HFA Nasal Aerosol 160 mcgCiclesonide HFA Nasal Aerosol 160 mcg once daily |
| HFA Nasal Aerosol placebo | Placebo comparator | Drug: HFA Nasal Aerosol placeboHFA Nasal Aerosol Placebo once daily |
| Ciclesonide Aqueous Nasal Spray 200 mcg | Experimental | Drug: Ciclesonide Aqueous Nasal Spray 200 mcgCiclesonide Aqueous Nasal Spray 200 mcg once daily |
| AQ Nasal Spray Placebo | Placebo comparator | Drug: AQ Nasal Spray PlaceboAQ Nasal Spray Placebo once daily |
| Placebo HFA plus Dexamethasone 6 mcg | Active comparator | Drug: Placebo plus Dexamethasone HFAPlacebo HFA plus Dexamethasone 6 mg once daily |
| Placebo AQ plus Dexamethasone 6 mg | Active comparator | Drug: Placebo AQ plus Dexamethasone 6 mgPlacebo AQ plus Dexamethasone 6 mg once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
- If any of the screening Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
- A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
- A demonstrated sensitivity to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to screening or performed at the Screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
Key exclusion criteria (18 listed)
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 120 days prior to the Screening visit.
- Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 mcgCiclesonide HFA Nasal Aerosol 320 μg once daily | Drug | Ciclesonide HFA Nasal Aerosol 320 mcg |
| Ciclesonide HFA Nasal Aerosol 160 mcgCiclesonide HFA Nasal Aerosol 160 μg once daily | Drug | Ciclesonide HFA Nasal Aerosol 160 mcg |
| HFA Nasal Aerosol placeboHFA Nasal Aerosol placebo once daily | Drug | HFA Nasal Aerosol placebo |
| Ciclesonide Aqueous Nasal Spray 200 mcgAlso: OmnarisCiclesonide Aqueous Nasal Spray 200 mcg once daily | Drug | Ciclesonide Aqueous Nasal Spray 200 mcg |
| AQ Nasal Spray PlaceboAQ Nasal Spray Placebo once daily | Drug | AQ Nasal Spray Placebo |
| Placebo plus Dexamethasone HFAAlso: DecadronDexamethasone capsules 6 mg once daily | Drug | Placebo HFA plus Dexamethasone 6 mcg |
| Placebo AQ plus Dexamethasone 6 mgPlacebo AQ plus Dexamethasone 6 mcg capsules once daily | Drug | Placebo AQ plus Dexamethasone 6 mg |
Primary outcome
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
Time frame: Baseline
AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period
Time frame: week 6
Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
42 secondary outcomes
Number of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Number of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Number of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Percentage of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Number of Subjects Experiencing Local Nasal AEs
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Local Nasal AEs
Time frame: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
Time frame: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
Time frame: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
Time frame: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM Reflective TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported PM Reflective TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM Instantaneous TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM and PM Reflective TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported PM Instantaneous TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM and PM Instantaneous TNSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM Reflective NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual PM Reflective NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Reflective NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM Instantaneous NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual PM Instantaneous NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
Time frame: Weeks 0-6
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
Time frame: Weeks 1-2, 2-4
Number of Devices With Actuation Consistency
Time frame: Weeks 1-4
Percentage of Devices With Actuation Consistency
Time frame: Weeks 1-4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg and Ciclesonide Aqueous Nasal Spray 200 mcg in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.