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

NCT00370591 | Completed Phase 4

• 1 other identifier: SAM40104
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of two asthma treatments by lung function measures.

Conditions

Asthma

Keywords

Inhaled corticosteroids; Asthma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Salmeterol/fluticasone propionate and fluticasone propionate

Interventions

Salmeterol/fluticasone propionate and fluticasone propionate DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Manchester, Lancashire, M23 9LT, United Kingdom

Location

Related Publications (2)

• This study has not been published in the scientific literature.

  BACKGROUND

• Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8(1):52. doi: 10.1186/1465-9921-8-52.

  PMID: 17629923 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: August 31, 2006
• Study Start: December 1, 2002
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)