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Sponsors and Collaborators: |
Northwestern University GlaxoSmithKline |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00741767 |
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Condition | Intervention |
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Chronic Obstructive Pulmonary Disease Sleep Disorders |
Drug: salmeterol-fluticasone |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD) |
Estimated Enrollment: | 36 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Patients randomized to receive salmeterol-fluticasone 250/50 twice daily for 4 weeks. Patients will cross-over and receive placebo medication for 4 weeks later in the study.
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Drug: salmeterol-fluticasone
250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily
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2
Patients randomized to receive placebo medication twice daily for 4 weeks. Patients will cross-over and receive study medication later in the study.
|
Drug: salmeterol-fluticasone
250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily
|
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 phenomena in patients with COPD. Several studies suggest sleep disturbance adversely affects quality of life and may worsen daytime pulmonary function in COPD patients. Improving sleep quality in patients with COPD, therefore, may not only improve health quality, but also attenuate the decline in daytime pulmonary function.
Previous studies investigating the effects of inhaled bronchodilators on sleep quality in COPD have shown conflicting results. These conflicting data prompted us to perform a retrospective study on patients with COPD and co-existing sleep apnea (OSA) investigating the effects of mechanical lung function impairment and lung hyperinflation on sleep. Our study found a significant correlation between increased lung hyperinflation and reduced sleep efficiency (a measure of sleep quality), and this relationship was preserved in a multivariable regression model.
We hypothesize that Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD. To test this hypothesis, we propose a double-blinded, placebo controlled cross-over study of Advair Diskus in patients with COPD and lung hyperinflation.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Poor subjective sleep quality: All subjects included must answer "yes" to at least one of the following questions:
Exclusion Criteria:
Contact: Michelle Morley, BA | 312-695-4828 | m-morley@northwestern.edu |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Michelle Morley, BA 312-695-4828 m-morley@northwestern.edu | |
Principal Investigator: Ravi Kalhan, MD, MS |
Principal Investigator: | Ravi Kalhan, MD, MS | Northwestern University |
Responsible Party: | Northwestern University ( Ravi Kalhan, MD, MS ) |
Study ID Numbers: | 3582 |
Study First Received: | August 22, 2008 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00741767 |
Health Authority: | United States: Institutional Review Board |
Chronic Obstructive Pulmonary Disease COPD Sleep Sleep quality Lung hyperinflation |
Signs and Symptoms Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Mental Disorders Lung Diseases |
Respiration Disorders Fluticasone Neurologic Manifestations Sleep Disorders Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |