A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
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|ClinicalTrials.gov Identifier: NCT00660517|
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : July 23, 2012
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: MP29-02 Drug: azelastine Hcl Drug: fluticasone propionate Drug: placebo||Phase 3|
This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day 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), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the 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. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the adult 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||607 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||April 2008|
azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray
azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day
Active Comparator: azelastine Hcl 548 mcg
azelastine Hcl 548 mcg nasal spray
Drug: azelastine Hcl
azelastine Hcl nasal spray one spray per nostril two times a day
Other Name: Astelin
Active Comparator: fluticasone propionate 200 mcg
fluticasone propionate 200 mcg nasal spray
Drug: fluticasone propionate
fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day
Other Name: generic Flonase
Placebo Comparator: placebo
placebo nasal spray
placebo nasal spray one spray per nostril two times a day
- Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: day 1 to day14 ]change from baseline in the 12 hour reflective total nasal symptoms 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.
- Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: day 1 to day 14 ]
change from baseline in the 12 hour instantaneous total nasal symptoms 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.
- Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days [ Time Frame: day 1 to day 14 ]Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660517
|United States, Texas|
|Allergy and Asthma Associates|
|Austin, Texas, United States, 78731|
|Central Texas Research|
|New Braunfels, Texas, United States, 78130|
|Southwest Allergy and Asthma Center, P.A.|
|San Antonio, Texas, United States, 78229|
|Sylvana Research Associates|
|San Antonio, Texas, United States, 78229|
|Allergy, Asthma Research Center|
|San Antonio, Texas, United States, 78258|
|Allergy and Asthma Care|
|Waco, Texas, United States, 76708|
|Allergy and Asthma Center|
|Waco, Texas, United States, 76712|
|Study Director:||Lewis M Fredane, MD||Meda Pharmaceuticals|