Perennial Allergic RhinitisPhase 3NCT01018862
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
A Phase 3 study testing Azelastine hydrochloride nasal spray 0.15% and Azelastine hydrochloride nasal spray 0.10% in people with Perennial Allergic Rhinitis, run by Meda Pharmaceuticals at 39 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Azelastine hydrochloride nasal spray 0.15% and Azelastine hydrochloride nasal spray 0.10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 489 participants
- Where
- 39 sitesUnited States
- Study dates
- Nov 2009to Apr 2011
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects >6-<12, inclusive at the screening visit
- At least a 1-year history of PAR
- The parent must provide written informed consent and the child must provide written assent.
- Willing and able to comply with the study requirements
- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit 1. A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter >5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
- Screening Visit: Have a 12-hour reflective TNSS of at least 6 out of a possible 12 and a congestion score of ≥2 or a rhinorrhea score of ≥2 on Visit 1
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- Randomization Visit: to be eligible for entry into the double-blind treatment period, subjects/caregivers must record:
- at least 3 symptom assessments (either AM or PM score) during the past 3 days of the Lead-In Period or the Day of Randomization:
- a 12-hour reflective TNSS ≥ 6
- a 12-hour reflective congestion score of ≥2 or a rhinorrhea score of ≥2
- the total of the seven Lead-In symptom assessments during the past 3 days of the Lead-In Period including the Day of Randomization (Visit 2/Day 1):
- a 12-hour reflective TNSS ≥ 42
- a 12-hour reflective congestion score of ≥14 or a rhinorrhea score of ≥14
- Must have taken at least 10 doses of study medication during the placebo Lead-In Period
- General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
- Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not preclude participation). Subjects receiving sublingual immunotherapy are excluded. A 6 month washout period is required following the last dose of sublingual immunotherapy.
Who cannot join
- On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation (Grade 1B - 4) (see section 8.1.4).
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis
- 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
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
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- Females who are pregnant or nursing
- Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Respiratory tract infections within two weeks prior to Visit 1
- Subjects with significant pulmonary disease including asthma. Subjects with intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
- Chronic obstructive sleep apnea syndrome (clinical diagnosis)
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the subject's ability to complete this trial.
- Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- Overnight absences from home for more than 3 nights
- Family members of research center or private practice personnel who are directly involved in this study are excluded
- Members of the same family cannot enroll in the study at the same time
- Subjects who have used the medications or therapies that could interfere with symptom evaluation within the time period specified (see Section 4.0).
- Any behavioral condition which could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Clinical Research Atlanta
Atlanta, Georgia, 30342
Isis Clinical Research, LLC
Ausitn, Texas, 78731
Central Texas Clinical Research
Austin, Texas, 78705
Sirius Clinical Research
Austin, Texas, 78759
Chesapeake Clinical Research, Inc
Baltimore, Maryland, 21236
Allergy and Asthma Consultants, LLP
Charleston, South Carolina, 29414
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Allergy and Asthma Consultants of NJ-PA, P.C
Collegeville, Pennsylvania, 19426
West Coast Clinical Trials
Costa Mesa, California, 92626
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
Intermountain Clinical Research
Draper, Utah, 84020
Idaho Allergy
Eagle, Idaho, 83616
Western Sky Medical Research
El Paso, Texas, 79902
Gary Steven, MD
Greenfield, Wisconsin, 53228
Clinical Research Institute of Indiana
Indianapolis, Indiana, 46208
Baker Asthma, Allergy and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Allergy, Asthma and Respiratory Care Center
Long Beach, California, 90806
Southern California Research
Mission Viejo, California, 92691
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, 73131
Joann Blessing-Moore,MD
Palo Alto, California, 94304
Asthma and Allergy Center, PC
Papillion, Nebraska, 68046
Clinical Research Institute
Plymouth, Minnesota, 55402
Allergy Associated Research Center
Portland, Oregon, 97213
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Island Medical Research
Rockville Centre, New York, 11570
Capital Allergy and Respiratory Disease Center
Sacramento, California, 95819
Sylvana Research Associates
San Antonio, Texas, 78229
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
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Marycliff Allergy Specialists
Spokane, Washington, 99204
Bensch Research Associates
Stockton, California, 95207
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Asthma, Sinus & Allergy Centers, LLC
Warren Township, New Jersey, 07059
Center for Allergy, Asthma and Immunology
Waterbury, Connecticut, 06708
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
Read the detailed description
in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Azelastine hydrochloride nasal spray 0.15%, Azelastine hydrochloride nasal spray 0.10%, 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.
Azelastine hydrochloride nasal spray 0.15%Drug
Also called Astepro 0.15%
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Azelastine hydrochloride nasal spray 0.10%Drug
Also called Astepro 0.10%
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
PlaceboDrug
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MP03-36 (0.15% solution) | Active comparator | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks Receives: Drug: Azelastine hydrochloride nasal spray 0.15% |
| MP03-33 (0.10% solution) | Active comparator | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks Receives: Drug: Azelastine hydrochloride nasal spray 0.10% |
| Placebo | Placebo comparator | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks 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 (TNSS) for the Entire 28-day Study Period Compared to Placebo
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Measured: baseline to 28 Days
Secondary outcomes (3)
Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Measured: baseline to 28 days
Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.
Measured: baseline to 28 days
Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.
Measured: baseline to 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionApr 2011
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 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
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ginsberg, DO, Study director, Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018862
- Sponsor's protocol ID
- MP441
- Status last verified
- May 2012
- First submitted
- 24 Nov 2009
- Last updated
- 11 Jun 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 11 Jun 2012. 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 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01018862
- Acronym / sponsor ID
- MP441
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 11 Jun 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 compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
Detailed description
in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)
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 |
|---|---|---|
| MP03-36 (0.15% solution) | Active comparator | Drug: Azelastine hydrochloride nasal spray 0.15%822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| MP03-33 (0.10% solution) | Active comparator | Drug: Azelastine hydrochloride nasal spray 0.10%548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Male and female subjects >6-<12, inclusive at the screening visit
- At least a 1-year history of PAR
- The parent must provide written informed consent and the child must provide written assent.
- Willing and able to comply with the study requirements
- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit 1. A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter >5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
Key exclusion criteria (18 listed)
- On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation (Grade 1B - 4) (see section 8.1.4).
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis
- 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
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 hydrochloride nasal spray 0.15%Also: Astepro 0.15%822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | Drug | MP03-36 (0.15% solution) |
| Azelastine hydrochloride nasal spray 0.10%Also: Astepro 0.10%548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | Drug | MP03-33 (0.10% solution) |
| Placebo0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Time frame: baseline to 28 Days
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
3 secondary outcomes
Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Time frame: baseline to 28 days
Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
Time frame: baseline to 28 days
Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
Time frame: baseline to 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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RecruitingObservational study
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Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Dupilumab Effects Against Aeroallergen Challenge
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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.
David Ginsberg, DO study director
Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs
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 hydrochloride nasal spray 0.15% and Azelastine hydrochloride nasal spray 0.10% in people with Perennial 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 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 11 Jun 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 11 Jun 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 (TNSS) for the Entire 28-day Study Period Compared to Placebo (time frame: baseline to 28 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 11 Jun 2012.