The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Chronic Obstructive Pulmonary Disease, Sleep Disorders
In brief
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Key facts
- Study ID
- NCT00741767
- Run by
- Northwestern University
- People needed
- 0
- Starts
- 2008-08-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2015-10-06
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Do you have trouble falling asleep?
- Do you have trouble staying asleep?
- Do you not get enough sleep?
- Do you wake up too early and not be able to get back to sleep?
- Do you fall asleep during the day?
You may not qualify if…
- 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
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.