Seasonal Allergic RhinitisPhase 3NCT00740792
A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
A Phase 3 study testing azelastine HCl/fluticasone propionate, azelastine Hcl and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 39 sites in United States.
Trial summary
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- azelastine HCl/fluticasone propionate, azelastine Hcl and fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 776 participants
- Where
- 39 sitesUnited States
- Study dates
- Aug 2008to Nov 2008
- 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
- Male and female subjects 12 years of age and older
- Provide written informed consent/pediatric assent. If the subject is a minor, parent or legal guardian must give written informed consent
- Subjects must have moderate-to-severe rhinitis, defined as having one or more of the following:
- Sleep disturbance
- Impairment of daily activities, leisure and/or sport
- Impairment of school or work
Show all 16Show fewer
- Troublesome symptoms
- Screening Visit: Have a 12-hour reflective TNSS of at least 8 of 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period.
- Randomization Visit: Have an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) Randomization Visit: Have an instantaneous TNSS score of 8 or more at time point zero, just prior to beginning the onset of action assessment
- Have taken at least 10 doses of the lead-in medication
- Willing and able to comply with the study requirementsAt least a 2-year history of SAR during Fall allergy season
- The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a positive response to skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control.
- General good health and free of disease or concomitant treatment that could interfere with the interpretation of the study results
- Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit
- Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.
Who cannot join
- On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at either the screening visit or randomization visit
- Other nasal disease(s) likely to affect deposition of intranasal medication
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year
- Planned travel outside of the pollen area during the study period
- The use of any investigational drug within 30 days prior to Day -7.
Show all 20Show fewer
- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception*
- Respiratory Tract Infections within 14 days prior to Day -7
- Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7
- Asthma (with the exception of intermittent asthma).
- Significant pulmonary disease including COPD
- Clinically significant arrhythmia or symptomatic cardiac conditions
- A known history of alcohol or drug abuse within the last 2 years
- Existence of any surgical or medical condition or physical or laboratory findings that could interfere with study result interpretation.
- Patients with a history of Glaucoma
- Clinically relevant abnormal physical findings within 1 week of randomization that may preclude compliance with the study procedures
- Employees of the research center or private practice and their family members are excluded
- Subjects who participated in protocol MP4001 or MP4002
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Clinical Research Atlanta
Atlanta, Georgia, 30342
Allergy and Asthma Associates
Austin, Texas, 78731
Allergy and Asthma Center of Austin
Austin, Texas, 78759
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 19426
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Jane Lee, MD, PA Research Center
Dallas, Texas, 75246
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Intermountain Clinical Research
Draper, Utah, 84020
Clinical Research Center
Encinitas, California, 92024
AABI Associates Medical Group
Fountain Valley, California, 92708
William Ebbling, MD Inc
Fresno, California, 93720
East Tennesse Center for Clinical Research
Knoxville, Tennessee, 37909
Allergy & Asthma Care Center of So. Cal
Long Beach, California, 90808
Allergy Research Foundation
Los Angeles, California, 90025
Clinical Reseacrh Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Atlantic Research Center
Ocean City, New Jersey, 07712
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210
The Asthma and Allergy Center
Papillion, Nebraska, 68046
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Clinical Research Institute
Plymouth, Minnesota, 55441
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group Inc
San Diego, California, 92120
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, 85251
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center
St Louis, Missouri, 63141
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, 30281
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Bensch Research Associates
Stockton, California, 95207
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, 07059
About this study
Official title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis.
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)
Read the detailed description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be rated, reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- azelastine HCl/fluticasone propionate, azelastine Hcl, fluticasone propionate, placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelastine HCl/fluticasone propionateDrug
Also called MP29-02
azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID
azelastine HclDrug
Also called azelastine hydrochloride
azelastine Hcl 548 mcg one spray per nostril BID
fluticasone propionateDrug
fluticasone propionate 200 mcg one spray per nostril BID
placeboDrug
placebo one spray per nostril BID
| Study group | Role | What they receive |
|---|---|---|
| azelastine HCl/fluticasone propionate | Experimental | nasal spray Receives: Drug: azelastine HCl/fluticasone propionate |
| azelastine HCL | Active comparator | nasal spray Receives: Drug: azelastine Hcl |
| fluticasone propionate | Active comparator | nasal spray Receives: Drug: fluticasone propionate |
| placebo | Placebo comparator | nasal spray Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)
change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement.
Measured: day1 to 14 days
Secondary outcomes (2)
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement.
Measured: day 1 to14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.
Measured: day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
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 Seasonal 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
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lewis M Fredane, MD, Study director, Meda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740792
- Sponsor's protocol ID
- MP4004
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2008
- Last updated
- 7 Sep 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 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT00740792
- Acronym / sponsor ID
- MP4004
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Posted 7 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)
Detailed description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be rated, reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| azelastine HCl/fluticasone propionate | Experimental | Drug: azelastine HCl/fluticasone propionatenasal spray |
| azelastine HCL | Active comparator | Drug: azelastine Hclnasal spray |
| fluticasone propionate | Active comparator | Drug: fluticasone propionatenasal spray |
| placebo | Placebo comparator | Drug: placebonasal spray |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female subjects 12 years of age and older
- Provide written informed consent/pediatric assent. If the subject is a minor, parent or legal guardian must give written informed consent
- Subjects must have moderate-to-severe rhinitis, defined as having one or more of the following:
- Screening Visit: Have a 12-hour reflective TNSS of at least 8 of 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period.
Key exclusion criteria (20 listed)
- On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at either the screening visit or randomization visit
- Other nasal disease(s) likely to affect deposition of intranasal medication
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year
- Planned travel outside of the pollen area during the study period
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 |
|---|---|---|
| azelastine HCl/fluticasone propionateAlso: MP29-02azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID | Drug | azelastine HCl/fluticasone propionate |
| azelastine HclAlso: azelastine hydrochlorideazelastine Hcl 548 mcg one spray per nostril BID | Drug | azelastine HCL |
| fluticasone propionatefluticasone propionate 200 mcg one spray per nostril BID | Drug | fluticasone propionate |
| placeboplacebo one spray per nostril BID | Drug | placebo |
Primary outcome
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)
Time frame: day1 to 14 days
change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement.
2 secondary outcomes
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: day 1 to14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: day 1 to day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Lewis M Fredane, MD study director
Meda Pharmaceuticals
39 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 azelastine HCl/fluticasone propionate, azelastine Hcl and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 39 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 16 inclusion and 20 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 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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 7 Sep 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?
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) (time frame: day1 to 14 days). 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 7 Sep 2012.