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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368445
• Other study ID #: MP433
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2011
• Last updated: October 5, 2011
• Start date: August 2006
• Est. completion date: April 2008

Study information

• Verified date: October 2011
• Source: Meda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: April 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• azelastine hydrochloride 0.15% Nasal Spray
1644 mcg, 2 sprays per nostril twice daily AM & PM)
• 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)
• Azelastine 0.1%, Nasal Spray
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)

Locations

Country	Name	City	State
United States	Allergy Asthma Associates Research Dept.	Austin	Texas
United States	Clinical Research Center	Cincinnati	Ohio
United States	Allergy and Asthma Consultants of NJ-PA, P.C	Collegeville	Pennsylvania
United States	The William Storms Allergy Clinic	Colorado Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Research Across America	Dallas,	Texas
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Valley Clinical Research Center	Easton	Pennsylvania
United States	Oklahoma Institute of Allergy and Asthma	Edmond	Oklahoma
United States	AABI Associates Medical Group	Fountain Valley	California
United States	West Coast Clinical Trials	Long Beach	California
United States	Allergy Research Foundation	Los Angeles	California
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	Northeast Medical Research Associates, Inc.	N. Dartmouth	Massachusetts
United States	Central Texas Health Research	New Braunfels	Texas
United States	Atlantic Allergy, Asthma & Immunology	Ocean	New Jersey
United States	Kansas City Allergy and Asthma	Overland Park	Kansas
United States	The Asthma and Allergy Center, PC	Papillion	Nebraska
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Allergy and Asthma Institue of Rochester	Rochester	New York
United States	Allergy Medical Group	Roseville	California
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy Associates Medical Group	San Diego	California
United States	Allergy and Asthma Associates of CA	San Jose	California
United States	Coastal Allergy and Asthma P.C.	Savannah	Georgia
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Allergy and Asthma Center	Waco	Texas
United States	Institute for Asthma and Allergy, P.C.	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo		14 Days	No
Secondary	Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo		14 Days	No
Secondary	Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo		14 Days	No
Secondary	Change From Baseline on Direct Visual Nasal Exams		14 Days	No