Perennial Allergic RhinitisPhase 3NCT00712920
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
A Phase 3 study testing 0.15% azelastine hydrochloride and 0.1% azelastine hydrochloride in people with Perennial Allergic Rhinitis, run by Meda Pharmaceuticals at 43 sites in United States.
Trial summary
The purpose of this study is to determine if two allergy medications are more effective than placebo. 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 0.1% azelastine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 581 participants
- Where
- 43 sitesUnited States
- Study dates
- Jan 2007to May 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 of age and older
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in protocol
- Must be willing and able to provide informed consent and participate in all study procedures
- 2-year history of PAR
- Positive skin test to cockroach, dust mite, mold or cat/dog dander
Who cannot join
- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- Nasal surgery or sinus surgery within the previous year
- The use of any investigational drug within 30 days
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
- Women who are pregnant or nursing
Show all 18Show fewer
- Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Respiratory tract infection within 2 weeks of screening
- Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
- Patients with asthma with the exception of mild, intermittent
- Significant pulmonary disease including COPD
- Patients with arrhythmia
- Patients with a known history of alcohol or drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
- Clinically relevant abnormal physical findings within one week of randomization
- Overnight abscences from home for more than 3 nights
- Employees of the research center or private practice and family members are excluded
- Patients who received prohibited medications within specified timepoints in protocol.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Allergy and Asthma Associates
Austin, Texas, 78731
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
The William Storms Allergy Clinic
Colorodo Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231
Las Vegas Physicians Research Group
Henderson, Nevada, 89052
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, 92647
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035
Allergy, Asthma and Respiratory Care medical Center
Long Beach, California, 90806
Allergy Research Foundation
Los Angeles, California, 90025
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Advanced Healthcare, SC
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 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
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
Virginia Adult & Pediactric Allergy & Asthma, PC
Richmond, Virginia, 23229
AAIR Research Center
Rochester, New York, 14618
Biogenics Research Institute
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group Inc
San Diego, California, 92120
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Asthma, Inc.
Seattle, Washington, 98105
The Clinical Research Center
St Louis, Missouri, 63141
Dr. Perin
Teaneck, New Jersey, 07666
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013
Allergy and Asthma Center
Waco, Texas, 76712
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
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 MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
The purpose of this study is to determine if two allergy medications are more effective than placebo.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- 0.15% azelastine hydrochloride, 0.1% azelastine hydrochloride, Placebo
- 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
0.15% azelastine hydrochloride 1644 mcg
0.1% azelastine hydrochlorideDrug
0.1% azelastine hydrochloride 1096 mcg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks Receives: Drug: 0.15% azelastine hydrochloride |
| 3 | Experimental | 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks Receives: Drug: 0.1% azelastine hydrochloride |
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 28 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 (LS Mean) 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 28 days
Secondary outcomes (4)
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 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.
Measured: baseline and 28 days
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
Reflective secondary symptom complex 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.
Measured: baseline and 28 days
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
A 28-item RQLQ was completed on Day 1 and Day 28 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. 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 28 Days
Change From Baseline on Direct Visual Nasal Exams and 28 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 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionMay 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712920
- Sponsor's protocol ID
- MP434
- Status last verified
- Jun 2011
- First submitted
- 8 Jul 2008
- Last updated
- 8 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023.
PubMed 37920410
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. 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 MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00712920
- Acronym / sponsor ID
- MP434
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- First posted
- 10 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 two allergy medications are more effective than placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: 0.15% azelastine hydrochloride0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks |
| 3 | Experimental | Drug: 0.1% azelastine hydrochloride0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 12 years of age and older
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in protocol
- Must be willing and able to provide informed consent and participate in all study procedures
- 2-year history of PAR
Key exclusion criteria (18 listed)
- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- Nasal surgery or sinus surgery within the previous year
- The use of any investigational drug within 30 days
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
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 hydrochloride0.15% azelastine hydrochloride 1644 mcg | Drug | 2 |
| 0.1% azelastine hydrochloride0.1% azelastine hydrochloride 1096 mcg | Drug | 3 |
| PlaceboPlacebo | Drug | 1 |
Primary outcome
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
Time frame: baseline and 28 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 (LS Mean) 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.
4 secondary outcomes
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
Time frame: baseline and 28 days
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
Time frame: baseline and 28 days
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
Time frame: baseline and 28 Days
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Time frame: baseline and 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37920410Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023.
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)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
The record lists no contact. Use the official record to reach the sponsor.
43 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 0.1% azelastine hydrochloride in people with Perennial Allergic Rhinitis, run by Meda Pharmaceuticals at 43 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 6 inclusion and 18 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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 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 in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. (time frame: baseline and 28 days). 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 NCT00712920, 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 8 Jun 2011.