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The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (AQuOS-COPD)
This study is currently recruiting participants.
Verified by Northwestern University, August 2008
Sponsors and Collaborators: Northwestern University
GlaxoSmithKline
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00741767
  Purpose

The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Sleep Disorders
Drug: salmeterol-fluticasone

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Sleep Disorders
Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate
U.S. FDA Resources
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)

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Changes in subjective measures of sleep quality [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Changes in objective measures of sleep and daytime cognitive function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in lung hyperinflation and systemic inflammation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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
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.
Drug: salmeterol-fluticasone
250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily
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

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741767

Contacts
Contact: Michelle Morley, BA 312-695-4828 m-morley@northwestern.edu

Locations
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            
Sponsors and Collaborators
Northwestern University
GlaxoSmithKline
Investigators
Principal Investigator: Ravi Kalhan, MD, MS Northwestern University
  More Information

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

Keywords provided by Northwestern University:
Chronic Obstructive Pulmonary Disease
COPD
Sleep
Sleep quality
Lung hyperinflation

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009