Seasonal Allergic RhinitisPhase 3NCT00883168
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
A Phase 3 study testing azelastineHcl, fluticasone propionate and azelastine Hcl/fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 45 sites in United States.
Trial summary
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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?
- azelastineHcl, fluticasone propionate and azelastine Hcl/fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,791 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2009to Jul 2009
- 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/female subjects 12 years of age and older
- Provide written informed consent/pediatric assent.
- Subjects must have moderate-to-severe rhinitis, with one or more of the following present:
- Sleep disturbance
- Impairment of daily activities, leisure and/or sport
- Impairment of school or work
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- Troublesome symptoms
- Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14
- Randomization Visit: instantaneous TNSS score of at least 8 and a congestion score of at least 2 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 requirements
- At least a 2-year history of SAR during the current allergy season
- The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal pollen, confirmed by a positive response to skin prick within the last year.
- General good health and free of any 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 (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
- 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 Visit 1. No investigational products are permitted for use during the conduct of this study
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- 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* see section 6.1.1
- Respiratory Tract Infections within 14 days prior to Visit 1
- Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1
- 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, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
- Patients with a history of glaucoma
- Clinically relevant abnormal physical findings within 1 week of randomization may preclude compliance with the study procedures
- Employees of the research center or private practice and their family members
- no more than 50% of their subjects have participated in protocol MP4001, MP4002 or MP4004
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 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
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Intermountain Clinical Research
Draper, Utah, 84020
Western Sky Medical Research
El Paso, Texas, 79902
Clinical Research Center
Encinitas, California, 92024
AABI Associates Medical Group
Fountain Valley, California, 92708
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
Family Allergy and Asthma Reserach
Louisville, Kentucky, 40215
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
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
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
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
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Diagnostic Research Group
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy, Asthma Research Center
San Antonio, Texas, 78258
Allergy Associates Medical Group Inc
San Diego, California, 92120
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, 85251
Asthma, Inc.
Seattle, Washington, 98105
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
Allergy and Asthma Center
Waco, Texas, 76712
Allergy Asthma Research Institute
Waco, Texas, 76712
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
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 the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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 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
- Placebo, azelastineHcl, fluticasone propionate, azelastine Hcl/fluticasone propionate
- 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.
PlaceboDrug
Placebo
azelastineHclDrug
Also called astelin
azelastine hydrochloride 548 mg
fluticasone propionateDrug
fluticasone propionate 200 mcg
azelastine Hcl/fluticasone propionateDrug
Also called MP29-02
azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| azelastine Hcl | Active comparator | Not described Receives: Drug: azelastineHcl |
| fluticasone propionate | Active comparator | Not described Receives: Drug: fluticasone propionate |
| azelastine Hcl /fluticasone propionate | Experimental | Not described Receives: Drug: azelastine Hcl/fluticasone propionate |
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 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.An greater negative value is suggestive of improvement.
Measured: day 1 to day 14
Secondary outcomes (2)
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
change from baseline in 12-hour instantaneous 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 score is suggestive of improved condition.
Measured: day 1 to day 14
Change From Baseline in Adult 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 posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionJul 2009
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
- 1,791 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
- NCT00883168
- Sponsor's protocol ID
- MP4006
- Status last verified
- Jun 2013
- First submitted
- 16 Apr 2009
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. 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
- NCT00883168
- Acronym / sponsor ID
- MP4006
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,791 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Apr 2009 (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 the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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 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 |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| azelastine Hcl | Active comparator | Drug: azelastineHcl |
| fluticasone propionate | Active comparator | Drug: fluticasone propionate |
| azelastine Hcl /fluticasone propionate | Experimental | Drug: azelastine Hcl/fluticasone propionate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Male/female subjects 12 years of age and older
- Provide written informed consent/pediatric assent.
- Subjects must have moderate-to-severe rhinitis, with one or more of the following present:
- Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14
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 (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
- 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 |
|---|---|---|
| PlaceboPlacebo | Drug | placebo |
| azelastineHclAlso: astelinazelastine hydrochloride 548 mg | Drug | azelastine Hcl |
| fluticasone propionatefluticasone propionate 200 mcg | Drug | fluticasone propionate |
| azelastine Hcl/fluticasone propionateAlso: MP29-02azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg | Drug | azelastine Hcl /fluticasone propionate |
Primary outcome
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)
Time frame: day 1 to day 14
change from baseline in 12-hour reflective 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.An greater negative value is suggestive of improvement.
2 secondary outcomes
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: day 1 to day 14
Change From Baseline in Adult 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 24 Jun 2013.
- 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.
Lewis M Fredane, MD study director
Meda Pharmaceuticals
45 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 azelastineHcl, fluticasone propionate and azelastine Hcl/fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 45 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 17 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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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: day 1 to day 14). 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 24 Jun 2013.