A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

October 5, 2011 updated by: Meda Pharmaceuticals

Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
617

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • AABI Associates Medical Group
      • Long Beach, California, United States, 90806
        • West Coast Clinical Trials
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • Roseville, California, United States, 95678
        • Allergy Medical Group
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates of CA
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • The William Storms Allergy Clinic
      • Denver, Colorado, United States, 80230
        • Colorado Allergy and Asthma Centers, PC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Coastal Allergy and Asthma P.C.
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Allergy and Asthma
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Institute for Asthma and Allergy, P.C.
    • Massachusetts
      • N. Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • The Asthma and Allergy Center, PC
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • Atlantic Allergy, Asthma & Immunology
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
    • New York
      • Rochester, New York, United States, 14618
        • Allergy and Asthma Institue of Rochester
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Clinical Research Center
    • Oklahoma
      • Edmond, Oklahoma, United States, 73003
        • Oklahoma Institute of Allergy and Asthma
    • Pennsylvania
      • Collegeville, Pennsylvania, United States, 19426
        • Allergy and Asthma Consultants of NJ-PA, P.C
      • Easton, Pennsylvania, United States, 18045
        • Valley Clinical Research Center
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
    • Texas
      • Austin, Texas, United States, 78731
        • Allergy Asthma Associates Research Dept.
      • Dallas, Texas, United States, 75231
        • AARA Research Center
      • Dallas,, Texas, United States, 75234
        • Research Across America
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research Associates
      • Waco, Texas, United States, 76712
        • Allergy and Asthma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 total nasal symptoms score ( 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 total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate 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 nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
  • Must have taken at least 10 doses of study medication during the lead-in period
  • Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
  • Willing and able to comply with the study requirements
  • At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
  • The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal 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
  • 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 who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.

Exclusion Criteria:

  • 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
  • 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 and not practicing a medically acceptable method of contraception
  • Respiratory tract infections within two weeks prior to Day -7
  • Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
  • Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
  • Patients with asthma (with the exception of mild, intermittent asthma)
  • Patients with significant pulmonary disease
  • 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, might significantly alter the absorption, distribution, metabolism, or excretion of study drug
  • 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
  • Planned travel outside the study area during the study period
  • Family members and employees should be excluded
  • Patients who received prohibited medications within specified timepoints in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MP03-36 Nasal Spray
azelastine hydrochloride 0.15%
Drug: azelastine hydrochloride 0.15% Nasal Spray
1644 mcg, 2 sprays per nostril twice daily AM & PM)
Other Names:
  • astepro .15%
Active Comparator: MP03-36 and Placebo Nasal Spray
azelastine hydrochloride 0.15% and Placebo
Drug: azelastine hydrochloride 0.15% and Placebo
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
Other Names:
  • Astepro.15%
Active Comparator: Azelastine 0.1%, Nasal Spray
Drug: Azelastine 0.1%, Nasal Spray
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)
Other Names:
  • Astepro
Placebo Comparator: Placebo Nasal Sapray
0mg, 2 sprays per nostril twice daily AM & PM)
Drug: azelastine hydrochloride 0.15% Nasal Spray
1644 mcg, 2 sprays per nostril twice daily AM & PM)
Other Names:
  • astepro .15%
Drug: azelastine hydrochloride 0.15% and Placebo
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
Other Names:
  • Astepro.15%
Drug: Azelastine 0.1%, Nasal Spray
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)
Other Names:
  • Astepro

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
Time Frame: 14 Days
14 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo
Time Frame: 14 Days
14 Days
Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo
Time Frame: 14 Days
14 Days
Change From Baseline on Direct Visual Nasal Exams
Time Frame: 14 Days
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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