Conditions: Asthma
Keywords: Allergic Rhinitis Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 725
Healthy volunteers: no

Brief summary:
This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Detailed description:
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Arms:
arm 1: Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD arm 2: FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD arm 3: Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD arm 4: Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD

Interventions: intervention 1: fluticasone propionate/salmeterol (FSC) intervention 2: montelukast (MON) intervention 3: fluticasone propionate (FP) intervention 4: placebo nasal intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS
Intervention descriptions: intervention 1: fluticasone propionate/salmeterol DISKUS combination intervention 2: montelukast capsule intervention 3: fluticasone propionate aqueous nasal spray intervention 4: vehicle placebo nasal spray intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS

Protocol document: