Status:
WITHDRAWN
The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Obstructive Pulmonary Disease
Sleep Disorders
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a common and clinically important disease characterized by chronic, irreversible airflow obstruction. Poor sleep quality and insomnia are well described...
Eligibility Criteria
Inclusion
- 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?
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00741767
Start Date
August 1 2008
End Date
February 1 2012
Last Update
October 6 2015
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611