Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.

Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370591

Enrollment

Registered

2006-08-31

Start date

2002-12-31

Completion date

2004-04-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Inhaled corticosteroids, Asthma

Brief summary

Comparison of two asthma treatments by lung function measures.

Detailed description

Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with persistent asthma treated for 4 weeks.

Interventions

DRUGSalmeterol/fluticasone propionate and fluticasone propionate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Inclusion: * Physician documented diagnosis of asthma which has been present for at least 6 months. * Receiving a total daily dose of 200-500mcg/day beclomethasone dipropionate or equivalent for at least 4 weeks prior to the start of the run-in period. Exclusion: * Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1

Design outcomes

Primary

Measure	Time frame
Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)	—

Secondary

Measure	Time frame
sRAW measured post-dose at Week 2 and week 4. % symptom-free days over Weeks 1-4. % symptom-free nights over Weeks 1-4. Type and frequency of adverse events.	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026