The effect of twice daily aclidinium bromide/formoterol fumarate 340/12 mcg vs. once daily tiotropium 'respimat' 5mcg on static and dynamic hyperinflation in patients with COPD during 24 hours.
Phase 4
Recruiting
- Conditions
- Chronic obstructive pulmonary disease (COPD)10006436
- Registration Number
- NL-OMON49226
- Lead Sponsor
- CIRO+, expertisecentrum voor chronisch orgaanfalen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
Patients with COPD with static hyperinflation above the higher limit of normal
defined as 1,64 times the standard deviation above the predicted value.
Exclusion Criteria
Patients treated with oral corticosteroids and/or antibiotics for an
exacerbation and/or lower respiratory tract infection in the 4 weeks prior to
screening.
Patients with hypercapnia (>= 6.5 kPa).
Patients unable to perform bodybox measurements
Known respiratory disorders other than COPD which may impact the efficacy of
the study drug.
Patients with clinically significant cardiovascular conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily<br /><br>compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour static<br /><br>hyperinflation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily<br /><br>compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour spirometry.<br /><br>To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily<br /><br>compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour dynamic<br /><br>hyperinflation.<br /><br>To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI<br /><br>twice daily compared to tiotropium respimat 5mcg PMDI once daily on 24 hour<br /><br>respiratory symptoms.<br /><br>To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI<br /><br>twice daily compared to tiotropium respimat 5mcg PMDI once daily on sleep<br /><br>quality.<br /><br>To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI<br /><br>twice daily compared to tiotropium respimat 5mcg PMDI once daily on nighttime<br /><br>physical activity, as an inverse surrogate for sleep quality.</p><br>