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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00974220
Eligibility Criteria:
Inclusion Criteria:
* Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio \<70%;
* Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
* A cigarette smoking history ≥20 pack-years;
* Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
* Body mass index (BMI) between 18.5 and 30.0 kg/m2;
* Able to perform all study procedures and provide/sign informed consent.
Exclusion Criteria:
* A diffusing capacity of the lung for carbon monoxide (DLCO) \<40 %predicted;
* Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
* Clinical diagnosis of sleep disordered breathing;
* A history/clinical evidence of asthma, atopy and/or nasal polyps;
* History of allergy or adverse reaction to fentanyl;
* Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
* Use of daytime oxygen or exercise-induced arterial oxygen desaturation to \<80% on room air;
* Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
* Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00974220
Study Brief:
Protocol Section:
NCT00974220