Last updated: 11/07/2018 16:55:19

A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Trial of Inhaled Fluticasone Propionate Rotadisk® Via Diskhaler 500mcg Bid, Multi-Dose Powder Inhaler 500mcg Bid, and Placebo in Adolescent and Adult Patients with Mild to Moderate Asthma

GSK study ID
FLTA2001
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Trial of Inhaled Fluticasone Propionate Rotadisk® Via Diskhaler 500mcg Bid, Multi-Dose Powder Inhaler 500mcg Bid, and Placebo in Adolescent and Adult Patients with Mild to Moderate Asthma
Trial description: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Trial of Inhaled Fluticasone Propionate Rotadisk® Via Diskhaler 500mcg Bid, Multi-Dose Powder Inhaler 500mcg Bid, and Placebo in Adolescent and Adult Patients with Mild to Moderate 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:
Falcoz C, Horton J, Mackie AE, Harding SM and Daley-Yates PT. Pharmacokinetics of inhaled fluticasone propionate delivered via the Diskhaler and Diskus delivery devices in patients with mild to moderate asthma. Clin. Pharmacokinet 39 (Suppl. 1):31-37, 2000
Galant, Stanley P MD; van Bavel, Julius MD; Finn, Albert MD; Gross, Gary MD; Pleskow, Warren MD; Brown, Alison BS; Hamedani, Abbas G MS; Harding, Stuart M MD. Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma Annals of Allergy, Asthma, & Immunology Volume 82(3) March 1999 pp 273-280
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
March 1994 to March 1996
Type
Not applicable
Phase
2

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1996-21-03

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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