Last updated: 11/07/2018 19:24:05
A Multi-Centre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Determine the Clinical Equivalence of Salmeterol Xinafoate 50mg Twice Daily Delivered via a Multi-dose Powder Inhaler (MDPI) or ROTADISK/DISKHALER in Adolescent and Adult Patients With Reversible Airways Disease
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, Double-Dummy, Parallel-Group Study to Determine the Clinical Equivalence of Salmeterol Xinafoate 50mg Twice Daily Delivered via a Multi-dose Powder Inhaler (MDPI) or ROTADISK/DISKHALER in Adolescent and Adult Patients With Reversible Airways Disease
Trial description: A Multi-Centre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Determine the Clinical Equivalence of Salmeterol Xinafoate 50mg Twice Daily Delivered via a Multi-dose Powder Inhaler (MDPI) or ROTADISK/DISKHALER in Adolescent and Adult Patients With Reversible Airways Disease
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:
Boulet LP. Cowie R. Johnston P. Krakovsky D. Mark S. Comparison of Diskus inhaler, a new multidose powder inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic patients. Canadian Study Group. Journal of Asthma. 32(6):429-36, 1995.
Medical condition
Asthma
Product
salmeterol
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
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
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
Not applicable
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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