Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT01656005
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe COPD (GOLD stage 2 and 3)
* FEV1 30-80% predicted
* No exacerbation in previous 3 months
* Smoking history ≥ 10 pack years
* Oxygen saturations≥ 92% on room air at rest
* ECG demonstrating sinus rhythm
Exclusion Criteria:
* Use of domiciliary oxygen
* History of other primary obstructive lung disease including asthma or bronchiectasis
* History of unstable angina, uncontrolled hypertension or heart failure NYHA class 3-4
* Overt clinical signs of right heart failure
* Average resting systolic BP\<110mmHg
* Average resting HR\<60bpm
* Pregnancy or lactation
* Known or suspected sensitivity to/intolerance of investigational medicinal product
* Inability to comply with compulsory aspects of protocol
* Any degree of heart block
* Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin or amiodarone
* Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol
* Participation in another trial within the previous 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01656005
Study Brief:
Protocol Section:
NCT01656005