Seasonal Allergic RhinitisPhase 3NCT00719862
A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
A Phase 3 study testing 0.15% azelastine hydrochloride Nasal Spray in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 34 sites in United States.
Trial summary
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- 0.15% azelastine hydrochloride Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 481 participants
- Where
- 34 sitesUnited States
- Study dates
- Aug 2007to Nov 2007
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be willing and able to provide informed consent and to participate in all study procedures
- Positive skin test to a prevalent fall allergen
Who cannot join
- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation 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, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- Nasal Surgery or sinus surgery within the previous year
- Chronic sinusitis-more than 3 episodes a year
- Planned travel outside of the study area during the study period
- The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
Show all 17Show fewer
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
- Respiratory tract infection within 14 days prior to screening
- Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
- Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
- Significant pulmonary disease including COPD
- Clinically significant arrythmia 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 laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, 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
- Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Chesapeake Clinical Research, Inc
Baltimore, Maryland, 21236
Asthma and Allergy Research Associates
Chester, Pennsylvania, 19013
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231
Jane Lee, MD, PA Research Center
Dallas, Texas, 75246
Valley Clinical Research
Easton, Pennsylvania, 18045
OIAA Clinical Research, LLC
Edmond, Oklahoma, 73003
Western Sky Medical Research
El Paso, Texas, 79902
Las Vegas Physicians Research Group
Henderson, Nevada, 89052
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, 92647
Colorado Allergy and Asthma centers, PC
Lakewood, Colorado, 80401
Allergy, Asthma and Respiratory Care medical Center
Long Beach, California, 90806
RX R+D
Metairie, Louisiana, 70001
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, 08054
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Allergy and Asthma Center of Michigan
Novi, Wisconsin, 48375
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, 68130
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210
The Asthma and Allergy Center
Papillion, Nebraska, 68046
UPMC-ENT
Pittsburgh, Pennsylvania, 15213
Clinical Research Institute
Plymouth, Minnesota, 55441
Asthma, Nasal Disease & Allergy Research Center of New England
Providence, Rhode Island, 02906
AAIR Research Center
Rochester, New York, 14618
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California, 95117
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, 31406
The Clinical Research Center
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Bensch Research Associates
Stockton, California, 95207
University of South Florida
Tampa, Florida, 33613
Allergy Consultants PA
Verona, New Jersey, 07044
Allergy Asthma Research Institute
Waco, Texas, 76712
Institute for Asthma and Allergy PC
Wheaton, Maryland, 20902
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188
About this study
Official title: Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo nasal spray, 0.15% azelastine hydrochloride Nasal Spray
- 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.
Placebo nasal sprayDrug
Placebo
0.15% azelastine hydrochloride Nasal SprayDrug
Also called astepro 0.15%
0.15% azelastine hydrochloride 822 mcg
| Study group | Role | What they receive |
|---|---|---|
| Placebo Nasal Spray | Placebo comparator | 0mg Placebo Nasal Spray Receives: Drug: Placebo nasal spray |
| 0.15% azelastine hydrochloride nasal spray | Active comparator | 0.15% azelastine hydrochloride Receives: Drug: 0.15% azelastine hydrochloride Nasal Spray |
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 (AM and PM Combined)at 14 Days
reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Measured: baseline and 14 days
Secondary outcomes (5)
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo
End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
Measured: baseline and 14 days
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Measured: baseline and 14-days
Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Measured: baseline and 14-days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Measured: baseline and 14 Days
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Measured: baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionNov 2007
- Study completionNov 2007
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
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lewis M Fredane, MD, Study director, Meda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719862
- Sponsor's protocol ID
- MP439
- Status last verified
- Jan 2010
- First submitted
- 21 Jul 2008
- Last updated
- 2 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00719862
- Acronym / sponsor ID
- MP439
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 28 Jan 2010
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 one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo nasal spray0mg Placebo Nasal Spray |
| 0.15% azelastine hydrochloride nasal spray | Active comparator | Drug: 0.15% azelastine hydrochloride Nasal Spray0.15% azelastine hydrochloride |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be willing and able to provide informed consent and to participate in all study procedures
- Positive skin test to a prevalent fall allergen
Key exclusion criteria (17 listed)
- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation 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, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- Nasal Surgery or sinus surgery within the previous year
- Chronic sinusitis-more than 3 episodes a year
- Planned travel outside of the study 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 |
|---|---|---|
| Placebo nasal sprayPlacebo | Drug | Placebo Nasal Spray |
| 0.15% azelastine hydrochloride Nasal SprayAlso: astepro 0.15%0.15% azelastine hydrochloride 822 mcg | Drug | 0.15% azelastine hydrochloride nasal spray |
Primary outcome
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
Time frame: baseline and 14 days
reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
5 secondary outcomes
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo
Time frame: baseline and 14 days
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
Time frame: baseline and 14-days
Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
Time frame: baseline and 14-days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
Time frame: baseline and 14 Days
Change From Baseline on Direct Visual Nasal Exams at 14 Days
Time frame: baseline and 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- 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
34 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 0.15% azelastine hydrochloride Nasal Spray in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 34 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 5 inclusion and 17 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 28 Jan 2010). 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 (AM and PM Combined)at 14 Days (time frame: baseline and 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 2 Feb 2010; AzTrials last refreshed its copy on 6 Nov 2026.