NL-OMON23638
Not yet recruiting
Not Applicable
A 12-week, multicentre, randomised, double-blind, double-dummy, 2-arm parallel group study comparing the efficacy and safety of Foster® 100/6 (beclomethasone dipropionate 100 µg plus formoterol 6 µg/actuation), 2 puffs b.i.d., versus Symbicort® 200/6 (budesonide 200 µg plus formoterol 6 µg/actuation), 2 inhalations b.i.d., on parameters of small airway function in patients with Chronic Obstructive Pulmonary Disease.
CROMSOURCE – Quality System Certified ISO 9001Lange Dreef 11H, NL-4131 NJ Vianen, The Netherlands0 sites144 target enrollmentTBD
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- CROMSOURCE – Quality System Certified ISO 9001Lange Dreef 11H, NL-4131 NJ Vianen, The Netherlands
- Enrollment
- 144
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study\-related procedure or when applicable written informed consent obtained by legal representative;
- •2\. Outpatients with a clinical diagnosis of moderate to severe COPD and including:
Exclusion Criteria
- •1\. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion;
- •2\. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post\-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or are using one or more of the following acceptable methods of contraception:
Outcomes
Primary Outcomes
Not specified
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