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

Sponsor
Meda Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01368445
Collaborator
(none)
617
Enrollment
30
Locations
4
Arms
20
Duration (Months)
20.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: azelastine hydrochloride 0.15% Nasal Spray
  • Drug: azelastine hydrochloride 0.15% and Placebo
  • Drug: Azelastine 0.1%, Nasal Spray
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
617 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo [14 Days]

    Secondary Outcome Measures

    1. Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo [14 Days]

    2. Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo [14 Days]

    3. Change From Baseline on Direct Visual Nasal Exams [14 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AABI Associates Medical Group Fountain Valley California United States 92708
    2 West Coast Clinical Trials Long Beach California United States 90806
    3 Allergy Research Foundation Los Angeles California United States 90025
    4 Southern California Research Mission Viejo California United States 92691
    5 Allergy Medical Group Roseville California United States 95678
    6 Allergy Associates Medical Group San Diego California United States 92120
    7 Allergy and Asthma Associates of CA San Jose California United States 95117
    8 The William Storms Allergy Clinic Colorado Springs Colorado United States 80907
    9 Colorado Allergy and Asthma Centers, PC Denver Colorado United States 80230
    10 Coastal Allergy and Asthma P.C. Savannah Georgia United States 31406
    11 Kansas City Allergy and Asthma Overland Park Kansas United States 66210
    12 Institute for Asthma and Allergy, P.C. Wheaton Maryland United States 20902
    13 Northeast Medical Research Associates, Inc. N. Dartmouth Massachusetts United States 02747
    14 Clinical Research Institute Minneapolis Minnesota United States 55402
    15 The Asthma and Allergy Center, PC Papillion Nebraska United States 68046
    16 Atlantic Allergy, Asthma & Immunology Ocean New Jersey United States 07712
    17 Princeton Center for Clinical Research Skillman New Jersey United States 08558
    18 Allergy and Asthma Institue of Rochester Rochester New York United States 14618
    19 North Carolina Clinical Research Raleigh North Carolina United States 27607
    20 Clinical Research Center Cincinnati Ohio United States 45231
    21 Oklahoma Institute of Allergy and Asthma Edmond Oklahoma United States 73003
    22 Allergy and Asthma Consultants of NJ-PA, P.C Collegeville Pennsylvania United States 19426
    23 Valley Clinical Research Center Easton Pennsylvania United States 18045
    24 Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania United States 15241
    25 Allergy Asthma Associates Research Dept. Austin Texas United States 78731
    26 Research Across America Dallas, Texas United States 75234
    27 AARA Research Center Dallas Texas United States 75231
    28 Central Texas Health Research New Braunfels Texas United States 78130
    29 Sylvana Research Associates San Antonio Texas United States 78229
    30 Allergy and Asthma Center Waco Texas United States 76712

    Sponsors and Collaborators

    • Meda Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meda Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01368445
    Other Study ID Numbers:
    • MP433
    First Posted:
    Jun 8, 2011
    Last Update Posted:
    Oct 6, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Seasonal
    Azelastine

    Study Results

    No Results Posted as of Oct 6, 2011