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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00169546




Registration number
NCT00169546
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
15/09/2016

Titles & IDs
Public title
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.
Scientific 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.
Secondary ID [1] 0 0
SAM40100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Salmeterol/fluticasone propionate
Treatment: Drugs - Fluticasone propionate

Experimental: Arm 1 -


Treatment: Drugs: Salmeterol/fluticasone propionate


Treatment: Drugs: Fluticasone propionate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Currently receiving 200-800mcg/day beclomethasone dipropionate.

- sRAW value of 1.3 kPa's.
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 3 or more courses of oral steroids in last 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Lancashire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Comparison of two asthma treatments by lung function measures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00169546
Trial related presentations / publications
This study has not been published in the scientific literature.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00169546