Last updated: 11/07/2018 19:24:20
A Multi-Centre, Randomised, Double-Blind, 12-Week, Parallel-Group Study to Compare Salmeterol Xinafoate 50mcg bd Delivered Either via a HFA Metered-Dose Inhaler or via a CFC Metered-Dose Inhaler, in the Treatment of Children Aged 4-11 Years With Asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Centre, Randomised, Double-Blind, 12-Week, Parallel-Group Study to Compare Salmeterol Xinafoate 50mcg bd Delivered Either via a HFA Metered-Dose Inhaler or via a CFC Metered-Dose Inhaler, in the Treatment of Children Aged 4-11 Years With Asthma
Trial description: A Multi-Centre, Randomised, Double-Blind, 12-Week, Parallel-Group Study to Compare Salmeterol Xinafoate 50mcg bd Delivered Either via a HFA Metered-Dose Inhaler or via a CFC Metered-Dose Inhaler, in the Treatment of Children Aged 4-11 Years With Asthma
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Chopra N, Rimmer M, Williams M, Jenkins M. Salmeterol metered dose inhaler (MDI) propelled by hydrofluoroalkane (HFA) is non-inferior to salmeterol chlorofluorocarbon (CFC) propelled MDI in paediatric patients with persistent asthma. Eur Respir J 2004; 24 (suppl 48): P3580. (abstract)
Chopra N, Williams M, Rimmer M, Kahl L, Jenkins M. Salmeterol HFA is as effective as salmeterol CFC in children and adults with persistent asthma. Respir Med 2005; 99: S1-S10.
Medical condition
Asthma
Product
salmeterol
Collaborators
Not applicable
Study date(s)
November 2002 to June 2003
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-25-06
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
Not applicable
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