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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT03824834
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 35 years and over
* Clinical diagnosis of COPD or ILD
* Cigarette smoking history ≥20 years (COPD only)
* Post bronchodilator FEV1 \<50% predicted and FEV1/FVC \<0.70 (COPD only)
* Chronic breathlessness syndrome (modified Medical Research Council dyspnea score ≥3; Baseline Dyspnea Index focal score ≤6; and/or an Oxygen Cost Diagram rating ≤50% full scale despite optimal treatment of the underlying pathophysiology according to evidence-based clinical practice guidelines
* Report breathlessness as the main limiting factor to incremental CPET
* Body mass index \>18.5 kg/m2 and \<35 kg/m2
Exclusion Criteria:
* Changed respiratory medication dosage and/or frequency of administration in preceding two weeks
* Disease exacerbation/hospitalization in preceding six weeks
* Arterialized capillary CO2 tension (PacCO2) \>50 mmHg at rest
* Self-reported history of drug addiction and/or substance abuse assessed with the CAIG-aid and SISAP questionnaires
* Severe excessive daytime sleepiness assessed with the Epworth Sleepiness Scale (score of 16 out of 24)
* Currently use anti-seizure and/or opioid drug(s)
* Use daytime supplemental oxygen
* Exercise-induced oxyhemoglobin desaturation to \<80% on room air
* Participated in a pulmonary rehabilitation program in preceding 6 months
* Allergy/sensitivity to opioid drugs
* Significant extra-pulmonary disease that could impair exercise tolerance
* Contraindication(s) to cardiopulmonary exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease)
* Pregnant or currently trying to become pregnant: women of child bearing potential (defined as having a menstrual period within the last 12 months) will be required to take a routine (urine) pregnancy test to rule out the possibility of pregnancy
* Self-report any of the following conditions: anemia or abnormally low blood volume; asthma; hypothyroidism; Addison's disease; renal insufficiency; hypopituitarism; severe malnutrition; digestive disease (any form of colitis disease); prostatic hypertrophy or urethral stricture
* Use of the blood thinning (anti-coagulant) drug Coumadin, Pradaxa, Xarelto and Eliquis in previous 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT03824834
Study Brief:
Protocol Section:
NCT03824834