Seasonal Allergic RhinitisPhase 3NCT00720278

A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

A Phase 3 study testing 0.15% azelastine hydrochloride 1644 mcg daily and 0.1% azelastine hydrochloride 1096 mcg daily in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was 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: Seasonal Allergic Rhinitis
What is being tested?: 0.15% azelastine hydrochloride 1644 mcg daily and 0.1% azelastine hydrochloride 1096 mcg daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 526 participants
Where: 29 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
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
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
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 Day -7
Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1)
Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
Must have taken at least 10 doses of study medication during the lead-in period

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Willing and able to comply with the study requirements
At least a 2-year history of SAR
The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test.
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. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
Patients 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 does not preclude participation). Patients 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 nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the patient from the study.
Other nasal disease(s) likely 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 per year
Planned travel outside of the study area during the study period
The use of any investigational drug within 30 days prior to Day -7. 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 and to either sorbitol or sucralose (Splenda® brand sweetener)
Women who are pregnant or nursing
Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
Respiratory Tract Infections within 14 days prior to Day -7
Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
Significant pulmonary disease including COPD
Clinically significant arrhythmia or with symptomatic cardiac conditions
A known history of alcohol or drug abuse
Existence of any surgical or medical condition or physical or 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 or that might significantly affect the patient'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
Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
Employees of the research center or private practice and their family members are excluded
Patients who received prohibited medications within specified timepoints in the protocol.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 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
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 19426
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
ENTA Allergy, Head and Neck Associates
Decatur, Illinois, 62526
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Clinical Research Center
Encinitas, California, 92024
East Tennesse Center for Clinical Research
Knoxville, Tennessee, 37909
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, 68505
Allergy Research Foundation
Los Angeles, California, 90025
Family Allergy and Asthma Reserach
Louisville, Kentucky, 40215
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
Center of Research Excellence, LLC
Oxford, Alabama, 36203
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Clinical Research Institute
Plymouth, Minnesota, 55441
North Carolina Clinical Research
Raleigh, North Carolina, 27607
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
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Allergy and Asthma Care
Waco, Texas, 76708
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, 07059

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 Compared to Placebo in Patients With Seasonal Allergic Rhinitis

The purpose of this study was to determine if two allergy medications are more effective than placebo.

Conditions: Seasonal Allergic Rhinitis
Being tested: 0.15% azelastine hydrochloride 1644 mcg daily, 0.1% azelastine hydrochloride 1096 mcg daily, Placebo
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.

0.15% azelastine hydrochloride 1644 mcg dailyDrug
Also called Astepro 0.15%
0.15% azelastine hydrochloride 1644 mcg daily
0.1% azelastine hydrochloride 1096 mcg dailyDrug
Also called Astepro 0.1%
0.1% azelastine hydrochloride 1096 mcg daily
PlaceboDrug
0 mcg Placebo daily

Study groups in NCT00720278
Study group	Role	What they receive
Placebo Nasal Spray	Placebo comparator	Placebo nasal spray Receives: Drug: Placebo
Astepro 0.1%	Experimental	0.1% azelastine hydrochloride nasal spray Receives: Drug: 0.1% azelastine hydrochloride 1096 mcg daily
Astepro 0.15%	Experimental	0.15% azelastine hydrochloride nasal spray Receives: Drug: 0.15% azelastine hydrochloride 1644 mcg daily

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)for the Entire 14-day Study Period Compared to Placebo
rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate.
Measured: baseline and 14 days

Secondary outcomes (4)

Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
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 the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) 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 to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
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.
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
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: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Nov 2007

First posted22 Jul 2008 (estimated)
Study startAug 2007
Primary completionOct 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: 526 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00720278
Sponsor's protocol ID: MP438
Status last verified: Feb 2010
First submitted: 21 Jul 2008
Last updated: 2 Mar 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
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Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

All Seasonal Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 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 MP03-36 and MP03-33 Compared to Placebo in Patients With Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT00720278
Acronym / sponsor ID: MP438
Conditions: Seasonal Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 526 participants (actual)
Lead sponsor: Meda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Oct 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 22 Jul 2008 (estimated)
Results: Posted 27 Oct 2009

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 was 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
Placebo Nasal Spray	Placebo comparator	Drug: PlaceboPlacebo nasal spray
Astepro 0.1%	Experimental	Drug: 0.1% azelastine hydrochloride 1096 mcg daily0.1% azelastine hydrochloride nasal spray
Astepro 0.15%	Experimental	Drug: 0.15% azelastine hydrochloride 1644 mcg daily0.15% azelastine hydrochloride nasal spray

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Male and female patients 12 years of age and older
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
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 Day -7
Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1)
Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1

Key exclusion criteria (20 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 patient from the study.
Other nasal disease(s) likely 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 per 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
0.15% azelastine hydrochloride 1644 mcg dailyAlso: Astepro 0.15%0.15% azelastine hydrochloride 1644 mcg daily	Drug	Astepro 0.15%
0.1% azelastine hydrochloride 1096 mcg dailyAlso: Astepro 0.1%0.1% azelastine hydrochloride 1096 mcg daily	Drug	Astepro 0.1%
Placebo0 mcg Placebo daily	Drug	Placebo Nasal Spray

Primary outcome

Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
Time frame: baseline and 14 days
rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate.

4 secondary outcomes

Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
Time frame: baseline and 14 Days
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Time frame: baseline and 14 days
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
Time frame: baseline and 14 days
Change From Baseline on Direct Visual Nasal Exams
Time frame: 14 days

Results and safety

Results posted to the registry on 27 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	178	171
Astepro 0.1%	170	166
Astepro 0.15%	178	172

Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo

Time frame: baseline and 14 days. Least squares mean (Standard Deviation). Unit: total nasal symptom score

Measure	Placebo n = 171	Astepro 0.1% n = 166	Astepro 0.15% n = 172
Baseline symptom score	17.86 (3.301)	18.29 (3.23)	17.83 (3.284)
Overall change from baseline	-2.36 (4.155)	-4.42 (4.696)	-5.36 (5.077)

Placebo vs Astepro 0.1%: Mean Difference (Final Values): -2.06 (95% CI -2.98 to -1.14), p <0.001, ANCOVA
Placebo vs Astepro 0.15%: Mean Difference (Final Values): -3.00 (95% CI -3.91 to -2.09), p <0.001, ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 178 (1.1%)	5 of 178 (2.8%)	Not reported
Astepro 0.1%	0 of 170 (0%)	21 of 170 (12.4%)	Not reported
Astepro 0.15%	0 of 178 (0%)	19 of 178 (10.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Seasonal Allergic Rhinitis

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 27 Oct 2009). 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)for the Entire 14-day Study Period Compared to Placebo (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?

On the ClinicalTrials.gov record for NCT00720278.

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 Mar 2010.