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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.

Efficacy and safety of aclidinium bromide 400 µg BID (twice a day)compared to placebo in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)

NCT ID

Therapeutic Area

1 puff of 400  micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)

1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

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A multiple dose, randomised, double-blind, placebo controlled, 2 period crossover clinical trial to assess the effect of aclidinium bromide 400 μg BID on exercise endurance in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)

Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.

Age Continuous

Gender, Male/Female

Region of Enrollment

Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.

Change from baseline in endurance time (seconds)

Change from baseline in trough IC after 3 weeks of treatment

Change from baseline in trough inspiratory capacity (IC) (Litres)

Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.

Change from baseline in intensity of dyspnoea

Treatment period 1

Treatment period 2

Eligible patients entered a 14-21 day run-in period to assess disease stability. During this period, one site visit was performed to familiarise patients with study testing procedures (body plethysmography, spirometry and a constant work rate cycle exercise test).

Arms	Assigned Interventions
Experimental: Aclidinium bromide 3-week treatment periods	Drug: Aclidinium Bromide 1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Experimental: Placebo 3-week treatment periods	Drug: Placebo 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

Efficacy and safety of aclidinium bromide 400 µg BID (twice a day)compared to placebo in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

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Study design

Verification:

Sponsors

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Inclusion Criteria

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Documents available

CSR Synopsis

Trial Results Summaries

Contacts

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Principal Investigator