Last updated: 11/07/2018 17:01:41
A multicentre, double-blind, placebo-controlled, parallel group study of the efficacy and tolerability of long-term inhaled fluticasone propionate 500mg twice daily via a Volumatic Spacer device in patients with non-asthmatic chronic obstructive pulmonary disease, including…
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 multicentre, double-blind, placebo-controlled, parallel group study of the efficacy and tolerability of long-term inhaled fluticasone propionate 500mg twice daily via a Volumatic Spacer device in patients with non-asthmatic chronic obstructive pulmonary disease, including…
Trial description: A multicentre, double-blind, placebo-controlled, parallel group study of the efficacy and tolerability of long-term inhaled fluticasone propionate 500mg twice daily via a Volumatic Spacer device in patients with non-asthmatic chronic obstructive pulmonary disease, including…
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:
Burge PS, Calverley PMA, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. Br Med J 2000; 320: 1297-1303.
Calverley PMA, Spencer S, Willits L, Burge PS, Jones PW. Withdrawals from treatment as an outcome in the ISOLDE study of COPD. Chest 2003; 124 (4): 1350-1356.
Jones PW, Willits LR, Burge PS, Calverley PMA. Disease severity and the effect of fluticasone propionate on chronic obstructive disease exacerbations. Eur Respir J 2003; 21 (1): 68-73.
Spencer S, Calverley PM, Burge PS, Jones PW. Heatlh Status deterioration in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001; 163: 122-128.
Spencer S, Calverley PMA, Burge PS, Jones PW. Impact of preventing exacerbations on deterioration of health status in COPD. Eur Respir J 2004; 23 (5): 698-702.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 1992 to March 1998
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
1998-31-03
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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