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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651118
• Other study ID #: MP4002
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: August 27, 2012
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2012
• 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 determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Description:

This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.

Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• 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 with a 2 year history of moderate to severe seasonal allergic rhinitis

• Must be in generally good health

• Must meet minimum symptom requirements, as specified in the protocol

• Must be wiling and able to provide informed consent and to participate all study procedures

• Positive skin test to a prevalent spring allergen

Exclusion criteria:

• On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation

• Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum

• Nasal or sinus surgery within the previous 6 months

• Chronic sinus infection (more than 3 per year)

• Planned travel outside the study area during the study period

• Use of any investigational drug within 30 days of the first visit

• Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)

• Women who are not using an acceptable method or birth control

• Women who are pregnant or nursing

• Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit

• Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator

• Irregular heartbeat or other symptomatic heart conditions

• History of alcohol or drug abuse

• History of glaucoma

• Use of medications that could affect the study results

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
placebo
• azelastine Hcl
azelastine Hcl 548 mcg
• azelastineHcl / fluticasone propionate
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
• fluticasone propionate
fluticasone propionate 200 mcg

Locations

Country	Name	City	State
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	Allergy and Asthma Associates	Austin	Texas
United States	Allergy and Asthma Center of Austin	Austin	Texas
United States	National Allergy, Asthma and Urticaria of Charleston	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Allergy and Consultants of NJ/PA	Collegeville	Pennsylvania
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Jane Lee, MD, PA Research Center	Dallas	Texas
United States	Colorado Allergy and Asthma Centers	Denver	Colorado
United States	Intermountain Clinical Research	Draper	Utah
United States	Clinical Research Center	Encinitas	California
United States	East Tennesse Center for Clinical Research	Knoxville	Tennessee
United States	Allergy Asthma and Dermatology Research	Lake Oswego	Oregon
United States	Colorado Allergy and Asthma Centers	Lakewood	Colorado
United States	Allergy, Asthma and Immunology Associates	Lincoln	Nebraska
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	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Atlantic Research Center	Ocean	New Jersey
United States	Kansas City Allergy and Asthma	Overland Park	Kansas
United States	The Asthma and Allergy Center	Papillion	Nebraska
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	AAIR Research Center	Rochester	New York
United States	Island Medical Research	Rockville Center	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy and Asthma Medical Group and Research Center	San Diego	California
United States	Aeroallergy Research Laboratories of Savannah	Savannah	Georgia
United States	Allergy, Asthma and Immunology Associates	Scottsdale	Arizona
United States	Asthma, Inc.	Seattle	Washington
United States	The Clinical Research Center	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Bensch Research Associates	Stockton	California
United States	Allergy Clinic of Tulsa	Tulsa	Oklahoma
United States	Asthma and Allergy Research Associate	Upland	Pennsylvania
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Research Asthma, Sinus and Allergy Centers	Warren	New Jersey

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 Symptom Score (rTNSS)	change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.; The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.	days 1 to 14	No
Secondary	Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.; The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.	day 1 to day 14	No
Secondary	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days	adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.; The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.	day 1 to day 14	No