Perennial Allergic RhinitisPhase 3NCT00720382
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
A Phase 3 study testing 0.15% azelastine hydrochloride and Mometasone furoate in people with Perennial Allergic Rhinitis, run by Meda Pharmaceuticals at 59 sites in United States.
Trial summary
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- 0.15% azelastine hydrochloride and Mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 59 sitesUnited States
- Study dates
- Mar 2007to Jul 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 patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
- Must be willing and able to provide informed consent and to participate in all study procedures
- Must be in generally good health
- Positive skin test to a prevalent perennial allergen
Who cannot join
- On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Use of any investigational drug within 30 days of the first visit
- Any nasal surgery or sinus surgery within the previous year
- Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
- Women who are pregnant or nursing
- Women who are not using an acceptable method of birth control
Show all 12Show fewer
- Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
- Patients with Arrythmia
- Patients with know history of alcohol and drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
- Use of medications that could affect the study results
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Georgia Pollens Clinical Research Centers Inc
Albany, Georgia, 31707
Allergy and Asthma Associates
Austin, Texas, 78731
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, 19422
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
New Horizon's Clinical Research
Cincinnati, Ohio, 45252
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 19426
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231
Oklahoma Institute of Allergy and Asthma Clinical
Edmond, Oklahoma, 73003
Western Sky Medical Research
El Paso, Texas, 79902
AABI Associates Medical Group
Fountain Valley, California, 92708
Las Vegas Physicians Research Group
Henderson, Nevada, 89052
SWAAA Research Center
Houston, Texas, 77074
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, 92647
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035
West Coast Clinical Trials
Long Beach, California, 90806
Allergy Research Foundation
Los Angeles, California, 90025
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
RX R+D
Metairie, Louisiana, 70001
Advanced Healthcare
Milwaukee, Wisconsin, 53209
Clinical Research Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, 08054
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Medical Research Associates of CNY, PLLC
North Syracuse, New York, 13212
Allergy and Asthma Care of Florida
Ocala, Florida, 34471
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
Center of Research Excellence, LLC
Oxford, Alabama, 36203
The Asthma and Allergy Center
Papillion, Nebraska, 68046
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Clinical Research Institute
Plymouth, Minnesota, 55441
Asthma, Nasal Disease & Allergy Research Center of New England
Providence, Rhode Island, 02906
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
VA Adult and Pediatric Allergy and Asthma
Richmond, Virginia, 23229
AAIR Research Center
Rochester, New York, 14618
Biogenics Research Institute
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233
Allergy Associates Medical Group Inc
San Diego, California, 92120
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
Asthma, Inc.
Seattle, Washington, 98105
The Clinical Research Center
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Bensch Research Associates
Stockton, California, 95207
Allergy and Asthma DTC
Tallahassee, Florida, 32308
Dr. Perin
Teaneck, New Jersey, 07666
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013
Allergy Asthma Research Institute
Waco, Texas, 76712
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Institute for Asthma and Allergy PC
Wheaton, Maryland, 20902
About this study
Official title: Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- 0.15% azelastine hydrochloride, Mometasone furoate
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.15% azelastine hydrochlorideDrug
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Mometasone furoateDrug
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.15% azelastine hydrochloride 1644 mcg Receives: Drug: 0.15% azelastine hydrochloride |
| 2 | Experimental | Mometasone furoate 200 mcg Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Direct Visual Nasal Exams to 12 Months
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 irritation 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: Change from baseline to 12 months
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 startMar 2007
- Primary completionJun 2008
- Study completionJul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 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
- NCT00720382
- Sponsor's protocol ID
- MP436
- Status last verified
- May 2015
- First submitted
- 21 Jul 2008
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Kumar Ramalingam R, Canonica GW, Berger WE. In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate. World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan.
PubMed 39885937
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00720382
- Acronym / sponsor ID
- MP436
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 15 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 treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 0.15% azelastine hydrochloride0.15% azelastine hydrochloride 1644 mcg |
| 2 | Experimental | Drug: Mometasone furoateMometasone furoate 200 mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
- Must be willing and able to provide informed consent and to participate in all study procedures
- Must be in generally good health
- Positive skin test to a prevalent perennial allergen
Key exclusion criteria (12 listed)
- On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Use of any investigational drug within 30 days of the first visit
- Any nasal surgery or sinus surgery within the previous year
- Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
- Women who are pregnant or nursing
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 |
|---|---|---|
| 0.15% azelastine hydrochloride1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM | Drug | 1 |
| Mometasone furoate200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM) | Drug | 2 |
Primary outcome
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Time frame: Change from baseline to 12 months
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 irritation 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39885937Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Kumar Ramalingam R, Canonica GW, Berger WE. In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate. World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
RecruitingPhase 2
PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Rhinitis Allergic
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal 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
59 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 and Mometasone furoate in people with Perennial Allergic Rhinitis, run by Meda Pharmaceuticals at 59 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 4 inclusion and 12 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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. 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 15 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 on Direct Visual Nasal Exams to 12 Months (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720382, which also lists 1 linked publication.
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 21 May 2015.