Last updated: 11/04/2018 11:14:43

Study In Airway Physiology In Children SERETIDE DISKUS ® inhlaer and FLIXOTIDE® inhaler are trademarks of GSK group of companies.

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GSK study ID
SAM40100
See study documents
Clinicaltrials.gov ID
NCT00169546
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 ® inhlaer 50/100mcg twice daily vs. FLIXOTIDE® inhaler 200mcg 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:

sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)

Timeframe: N/A

Secondary outcomes:

sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.

Timeframe: N/A

Interventions:
Drug: Salmeterol/fluticasone propionate
Drug: Fluticasone propionate
Enrollment:
64
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)
January 2003 to December 2005
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
  • Currently receiving 200-800mcg/day beclomethasone dipropionate.
  • sRAW value of 1.3 kPa's.
  • 3 or more courses of oral steroids in last 12 months.
Inclusion and exclusion criteria
Inclusion criteria:
  • Currently receiving 200-800mcg/day beclomethasone dipropionate.
  • sRAW value of 1.3 kPa's.
Exclusion criteria:
  • 3 or more courses of oral steroids in last 12 months.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Study Complete
Contact us
Location
GSK Investigational Site
Wellington, New Zealand, 6004
Status
Study Complete
Contact us

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
2005-20-12

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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