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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370591
• Other study ID #: SAM40104
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2006
• Last updated: September 13, 2016
• Start date: December 2002
• Est. completion date: April 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Comparison of two asthma treatments by lung function measures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/fluticasone propionate and fluticasone propionate

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
Secondary	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.

External Links

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