Phase 4 N=81 Randomized Double-blind Treatment

SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00461500 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12 — 59.21; 50.98 Liters per minute (L/min) — p=0.683

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Salmeterol xinafoate/fluticasone propionate combination (Drug); Fluticasone propionate (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12	59.21; 50.98	0.683
SECONDARY Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)	0.25; 0.11	—
SECONDARY Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)	7.46; 4.97	—
SECONDARY Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)	-9.46; -4.05	—
SECONDARY Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)	0.18; 0.14	—
SECONDARY Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)	7.24; 4.28	—
SECONDARY Number of Participants With at Least One Exacerbation During 12-Week Treatment Period	1; 5; 0; 0	—
SECONDARY Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12	13; 11; 16; 24	—
SECONDARY Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12	3.1; 4.1	—
SECONDARY Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12	1; 1; 28; 35	—
SECONDARY Change From Baseline in Asthma Control Test (ACT) Score at Week 12	5.64; 5.90	—
SECONDARY ACT Score in Classes at Week 12	5; 2; 12; 15; 16; 25	—
SECONDARY Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12	0.99; 1.11	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00461500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.