Clinical trial NCT00461500: SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults
Official title: Seretide 100 DK vs Flixotide 100 DK in IMT in Moderate Asthma in Adults on Static Lung Volumes (Mechanistic Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: persistent
moderate
asthma
adults
Initial
Maintenance
Therapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma

Detailed description: A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma

Eligibility criteria: Inclusion criteria:

* male or female ≥ 18
* documented history of asthma
* reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
* moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
* naive or ≥ 4weeks-free ICS (inhaled corticosteroids)

Exclusion criteria:

* respiratory disorder
* FEV1\<60% predicted
* exacerbation/respiratory infection ≤ 4 weeks
* oral/parenteral/depot corticosteroids ≤ 6 months
* LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
* smoker or former smoker ≥ 5 packs year

Primary outcomes:
measure: Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12
timeFrame: Baseline, Weeks 5-12
Secondary outcomes:
measure: Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame: Baseline through Week 12
measure: Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame: Baseline through Week 12
measure: Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame: Baseline through Week 12
measure: Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame: Baseline through Week 12
measure: Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame: Baseline through Week 12
measure: Number of Participants With at Least One Exacerbation During 12-Week Treatment Period
timeFrame: 12-Week Treatment Period (Week 1 through Week 12)
measure: Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12
timeFrame: Weeks 5 -12
measure: Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12
timeFrame: Weeks 5 - 12
measure: Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12
timeFrame: Weeks 5 - 12
measure: Change From Baseline in Asthma Control Test (ACT) Score at Week 12
timeFrame: Baseline, Week 12
measure: ACT Score in Classes at Week 12
timeFrame: Week 12
measure: Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: