Rhinitis, Allergic, Perennial and SeasonalPhase 4NCT01916226
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
A Phase 4 study testing FPNS and Cetirizine in people with Rhinitis, Allergic, Perennial and Seasonal, run by GlaxoSmithKline at 31 sites in United States.
Trial summary
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial and Seasonal
- What is being tested?
- FPNS and Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 682 participants
- Where
- 31 sitesUnited States
- Study dates
- 1 Aug 2013to 17 Oct 2013
- Phase
- Phase 4
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent: Subject must give their signed and dated written informed consent to participate. Subject must understand and be willing, able, and likely to comply with study procedures and restrictions. Subject must be able to read, comprehend, and record information in English.
- Subject is treatable on an outpatient basis.
- Age: >=18 years of age at Visit 1.
- Gender: Male or eligible female subjects. A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. OR Childbearing potential with a negative pregnancy test at screening and agreeable to using one of the acceptable contraceptive methods consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study). An eligible female is also not lactating nor planning on becoming pregnant during the study.
- Diagnosis of SAR, defined as documented clinical history or physician verification of subject reported historical SAR during each of the last two fall allergy seasons and a positive skin prick test (wheal >=3 millimeter [mm] larger than the negative control) to a prevalent local fall allergen within 12 months prior to Visit 1 or at Visit 1.
- Adequate exposure to local fall pollen: Subject resides within a geographical region where exposure to the local fall pollen to which they are sensitized is expected to be moderate or greater during the study period. Subject does not plan to travel outside the geographical region where exposure to local fall pollen to which they are sensitized is expected to be moderate or greater for more than 48 hours during the study period.
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- At Visit 2, the subject must meet the following criteria
- Eligible subjects will need to have moderate to severe SAR symptoms, defined as a morning rTNSS of >=7 on at least four of the last seven days leading up to randomization. This includes the AM assessment on the morning of the randomization visit at Visit 2.
- Subjects should demonstrate at least a 70% compliance rate with both their placebo run-in study medications and their e-diary completion prior to randomization. This period includes the day of Visit 1 until the day before randomization at Visit 2.
- Subjects should have no significant change in medical condition(s) that would have been exclusionary at Visit 1.
- Subjects should not have used any prohibited medications that are detailed in the inclusion/exclusion criteria (including prohibited allergy medications).
- Subjects should not have travelled outside the local pollen region for more than 48 hours during the run-in period.
Who cannot join
- Significant concomitant medical conditions, defined as but not limited to:
- Historical or current evidence of a clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, uncontrolled asthma). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
- A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug.
- Nasal (e.g., nasal septum), ocular, or throat injury, or surgery to these areas in the last 3 months.
- Rhinitis medicamentosa. Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period.
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator.
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- Current or history of glaucoma and/or cataracts or ocular herpes simplex. Physical impairment that would affect subject's ability to safely and fully participate in the study.
- Clinical evidence of a Candida infection of the nose. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results.
- History of adrenal insufficiency.
- Use of corticosteroids, defined as: Intranasal corticosteroid within four weeks prior to Visit 1 and during the treatment period. Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1 and during the treatment period.
- Use of allergy medications, within a timeframe relative to Visit 1, that would prevent the medication from being eliminated and/or have an effect. Exclusionary timeframes relative to Visit 1 for five common allergy treatments are noted below Intranasal cromolyn (<=2 weeks from Visit 1). Intranasal or systemic decongestants (<=3 days from Visit 1). Intranasal or systemic (other than oral) antihistamines (<=3 days from Visit 1).
- Leukotriene modifiers (<=3 days from Visit 1). Oral antihistamines (<=2 days from Visit 1). Allergy medications, other than study supplied medications, are not allowed during the study.
- Use of other medications that may affect allergic rhinitis or its symptoms, e.g., use of any ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods
- Use of any medications (prescription or non-prescription) or alcohol to induce sleep 48-hours prior to Visit 1 and during the treatment period.
- Use of other intranasally administered medications (e.g., calcitonin), including herbals and homeopathics during the run-in (Visit 1 - Visit 2) and treatment period.
- Use of immunosuppressive medications within 8 weeks prior to screening and during the treatment period.
- Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4 (e.g., ritonavir, ketoconazole) during the run-in (Visit 1 - Visit 2) and treatment period.
- Known hypersensitivity to corticosteroids or any excipients present in the nasal spray.
- Known hypersensitivity to cetirizine or any excipients in the tablet.
- Recent exposure to an investigational study drug or device within 30 days of Visit 1.
- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
- Chickenpox or measles during the last 3 weeks prior to screening and is non-immune.
- Immunotherapy is exclusionary unless the immunotherapy was initiated >=30 days from Visit 1 and if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bellevue, Nebraska, 68123-4303
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Greenfield, Wisconsin, 53228
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
Lenexa, Kansas, 66215
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Overland Park, Kansas, 66210
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: Study 200165, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Compare the Efficacy of a 2-Week Treatment With Fluticasone Propionate Nasal Spray Versus Cetirizine in Adult Subjects With Seasonal Allergic Rhinitis (SAR)
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.
- Being tested
- FPNS, FPNS Placebo, Cetirizine, Cetirizine Placebo
- Keywords
- cetirizine, seasonal allergic rhinitis, Quality of Life, fluticasone propionate nasal spray
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPNSDrug
Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray.
FPNS PlaceboDrug
Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays.
CetirizineDrug
Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle).
Cetirizine PlaceboDrug
Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).
| Study group | Role | What they receive |
|---|---|---|
| FPNS arm | Experimental | Subject will receive two sprays (200 mcg per day)of FP into each nostril once daily (OD) every morning for 14 days Receives: Drug: FPNS |
| FPNS Placebo arm | Placebo comparator | Subject will receive two sprays of FP placebo into each nostril OD every morning for 14 days Receives: Drug: FPNS Placebo |
| Cetirizine arm | Experimental | Subject will receive Cetirizine capsule by mouth OD in the morning for 14 days Receives: Drug: Cetirizine |
| Cetirizine Placebo arm | Placebo comparator | Subject will receive Cetirizine Placebo capsule by mouth OD in the morning for 14 days Receives: Drug: Cetirizine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period
The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Measured: Baseline through the entire treatment period (2 weeks)
Secondary outcomes (6)
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period
Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Measured: Baseline through the entire treatment period (2 weeks)
Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.
The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.
Measured: Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period
The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that "instant." The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.
Measured: Baseline through the entire treatment period (2 weeks)
Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Measured: Baseline through the entire treatment period (2 weeks)
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period
The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that "instant." The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Measured: Baseline through the entire treatment period (2 weeks)
Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period
The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.
Measured: Baseline through the entire treatment period (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion1 Oct 2013
- Study completion17 Oct 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, Perennial and SeasonalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916226
- Sponsor's protocol ID
- 200165
- Status last verified
- Jun 2018
- First submitted
- 1 Aug 2013
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Ford LB, Matz J, Hankinson T, Prillaman B, Georges G. A comparison of fluticasone propionate nasal spray and cetirizine in ragweed fall seasonal allergic rhinitis. Allergy Asthma Proc. 2015 Jul-Aug;36(4):313-9. doi: 10.2500/aap.2015.36.3860.
PubMed 26108088