Asthma
Conditions
Keywords
Asthma, Allergic Rhinitis
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
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have asthma for at least 3 months prior to the study. * Have been using an allowed pre-study asthma therapy for at least 3 months prior to study. * Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons. * Have a positive allergy skin test.
Exclusion criteria
* Have a history of life-threatening asthma. * Been hospitalized for asthma within the 6 months prior to the study. * Have certain conditions that would make study participation unsafe. The study doctor will evaluate other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning Peak Expiratory Flow | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days | — |
Countries
United States
Outcome results
None listed