Last updated: 11/03/2018 05:41:08

A double-blind, randomized, placebo-controlled, double-dummy, four-way cross-over study to evaluate the bronchodilatory effect of single doses tioptropium bromide (18 mcg administered via dry-powder inhaler [DPI]) and salmeterol (50 or 100 mcg via DPI) in patients with bronchodilator responsive COPD.

GSK study ID
100539
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 double-blind, randomized, placebo-controlled, double-dummy, four-way cross-over study to evaluate the bronchodilatory effect of single doses tioptropium bromide (18 mcg administered via dry-powder inhaler [DPI]) and salmeterol (50 or 100 mcg via DPI) in patients with bronchodilator responsive COPD.
Trial description: A double-blind, randomized, placebo-controlled, double-dummy, four-way cross-over study to evaluate the bronchodilatory effect of single doses tioptropium bromide (18 mcg administered via dry-powder inhaler [DPI]) and salmeterol (50 or 100 mcg via DPI) in patients with bronchodilator responsive COPD.
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:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
ipratropium bromide, salmeterol
Collaborators
Not applicable
Study date(s)
December 2003 to August 2004
Type
Not applicable
Phase
1

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
2004-04-08

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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