Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo
The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and are currently available by prescription at your drug store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and one is for treatment of both SAR and asthma. In addition, you will also receive one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may experience throughout the study.
The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
Seasonal Allergic Rhinitis
Drug: Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray Versus Montelukast in Adolescents/Adults With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus(R) or Placebo|
- Mean change from baseline at endpoint in morning PEF compared between fluticasone propionate/salmeterol combination product 100/50mcg BID (FSC) and montelukast 10mg QD (MON) treatment groups.
- Assess superiority and compare between FSC and FSC+MON treatment groups
- Assess equivalence.
- Rhinitis mean change from baseline in subject-rated: daily, total nasal symptom scores averaged over Weeks 1-2 and nighttime total nasal symptom scores averaged over Weeks 1-2.
- Asthma assess superiority and assess equivalence: mean change from baseline at endpoint in predose AM FEV1; percentage of asthma rescue-free days; and percentage of asthma rescue-free days
|Study Start Date:||April 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385463
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Robert Townley, M.D.||Creighton University|