Last updated: 11/07/2018 19:21:29
A Single Centre, Randomised, Double-Blind, Cross-Over Study to Compare the Efficacy of Inhaled Salmeterol Xinafoate Dry Powder 50mg BID via the Diskhaler with Placebo Dry Powder BID via the Diskhaler in the Treatment of Non-Reversible COPD Patients and to Provoke with Histamine and…
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 Single Centre, Randomised, Double-Blind, Cross-Over Study to Compare the Efficacy of Inhaled Salmeterol Xinafoate Dry Powder 50mg BID via the Diskhaler with Placebo Dry Powder BID via the Diskhaler in the Treatment of Non-Reversible COPD Patients and to Provoke with Histamine and…
Trial description: A Single Centre, Randomised, Double-Blind, Cross-Over Study to Compare the Efficacy of Inhaled Salmeterol Xinafoate Dry Powder 50mg BID via the Diskhaler with Placebo Dry Powder BID via the Diskhaler in the Treatment of Non-Reversible COPD Patients and to Provoke with Histamine and…
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:
Abstract: Ulrik, C S, 10800. The Efficacy of Inhaled Salmeterol in the Management of Smokers with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [9/16/1995]. 9/20/1995: Ulrik, C S, 3/9/2003. 4th Annual Meeting of the European Respiratory Society; Barcelona; Spain. 1995 Sep 16; c1995.
Suppli Ulrik C. Airway responsiveness in COPD: Effect of salmeterol? Eur Respir J 1998;12 suppl 28:1s.
Ulrik CS. Airway responsiveness in COPD: Effect of salmeterol. Am J Respir Crit Care Med 1998;157(3):A801.
Ulrik CS. Efficacy of inhaled salmeterol in the management of smokers with chronic obstructive pulmonary disease: a single centre randomised, double blind, placebo controlled, crossover study. Thorax 1995; 50, 750-754
Ulrik CS. The efficacy of inhaled salmeterol in the management of smokers with moderate to severe COPD. Am J Respir Crit Care Med 1995;151(4 Part 2):A462.
Ulrik, C. S. (Lungemedicinsk afdeling P, Bispebjerg Hospital, Kobenhavn.). [The effect of salmeterol in the treatment of smokers with chronic obstructive lung disease]: Effekten af salmeterol i behandlingen af rygere med kronisk obstruktiv lungesygdom. [dan]. Ulrik, C S. Ugeskr Laeger. 1996 Jun 17; 158(25):3604-7; ISSN: Clinical Trial. Journal Article. Randomized Controlled Trial. 0 (Adrenergic beta-Agonists). 0 (Bronchodilator Agents). 18559-94-9 (Albuterol). 89365-50-4 (salmeterol). Adrenergic beta-Agonists/*therapeutic use. Adult. Albuterol/*analogs & derivatives/therapeutic use. Bronchodilator Agents/*therapeutic use. Cross-Over Studies. Double-Blind Method. English Abstract. Female. Humans. Lung Diseases, Obstructive/*drug therapy/etiology/physiopathology. Lung Volume Measurements. Male. Middle Aged. Smoking/*adverse effects.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
salmeterol
Collaborators
Not applicable
Study date(s)
February 1992 to July 1993
Type
Not applicable
Phase
4
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
1993-01-07
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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