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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00741767
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 40 years of age
* BMI\<30
* Former smokers with ≥ 10 pack-year history
* Diagnosis of COPD, as defined by the American Thoracic Society (FEV1/FVC \< 70 with history of exposure to noxious particles or gases)
* Moderate to severe COPD as defined as an FEV1 ≤ 80% predicted
* Functional residual capacity \> 120% or inspiratory capacity \< 80% predicted on pulmonary function testing
* Poor subjective sleep quality: All subjects included must answer "yes" to at least one of the following questions:
1. Do you have trouble falling asleep?
2. Do you have trouble staying asleep?
3. Do you not get enough sleep?
4. Do you wake up too early and not be able to get back to sleep?
5. Do you fall asleep during the day?
Exclusion Criteria:
* Conditions that in the judgment of the investigator would interfere with subject participation in the study
* BMI \> 30
* History of or physician diagnosed pulmonary disorder other than COPD
* History of significant obstructive sleep disordered breathing (apnea-hypopnea index \> 15) or presence of central sleep apnea
* History of narcolepsy, primary hypersomnia, periodic limb movement disorder, or parasomnia
* History of psychiatric illness
* Presence of decompensated heart failure
* Use of prednisone, antibiotic therapy, or new medication for COPD in the previous 3 months
* Use of any sleep aids
* History of ≥ 1 COPD exacerbation (defined as requiring oral corticosteroids and/or antibiotics as either an outpatient or inpatient)
* Known allergy or significant adverse reactions to inhaled beta2-agonists and inhaled corticosteroids (not including thrush and dysphonia)
* Pregnancy or lactating
* Inability or unwillingness to provide informed consent
* Inability to effectively use study medication or perform baseline measurements
* Inability to be contacted by phone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00741767
Study Brief:
Protocol Section:
NCT00741767