Last updated: 11/04/2018 11:15:15

Study Of Airway Physiology In Adults. SERETIDE DISKUS® inhaler and FLIXOTIDE® inhaler are trademarks of GSK croup of companies.

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GSK study ID
SAM40104
See study documents
Clinicaltrials.gov ID
NCT00370591
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: Comparison of two asthma treatments by lung function measures.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: N/A

Secondary outcomes:

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.

Timeframe: N/A

Interventions:
Drug: Salmeterol/fluticasone propionate and fluticasone propionate
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
December 2002 to April 2004
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
  • Inclusion:
Inclusion and exclusion criteria
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

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-16-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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