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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Salmeterol/fluticasone propionate and fluticasone propionate

• Registration Number: NCT00370591
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Salmeterol/fluticasone propionate and fluticasone propionate	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, Lancashire, United Kingdom