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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01592656
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥ 40 years old
* Men and women
* Written informed consent obtained
* COPD patients GOLD II, III and IV
* Persisting hypercapnia (pCO2 \> 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
* Stopped smoking
* Total lung capacity (TLC) \> 85%
Exclusion Criteria:
* Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
* Asthma
* Restrictive lung disease
* Symptomatic or uncontrolled heart failure
* Current malignancy
* Suspected bad compliance for NIV treatment
* Pregnant women
* Not be able to speak the language of the participating center
* Received an investigational product within 4 weeks prior to inclusion in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01592656
Study Brief:
Protocol Section:
NCT01592656