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The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (AQuOS-COPD)

This study has been withdrawn prior to enrollment.
(Study subject enrollment difficulties)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ravi Kalhan, Northwestern University
ClinicalTrials.gov Identifier:
NCT00741767
First received: August 22, 2008
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD)

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: February 2012
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Salmeterol-fluticasone
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
Other Name: Advair Diskus
Placebo
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
Other Name: Advair Diskus

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.

It was mutually decided by the sponsor and principal investigator to terminate the study early due to study subject enrollment difficulties.

  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

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
GlaxoSmithKline
Investigators
Principal Investigator: Ravi Kalhan, MD, MS Northwestern University
  More Information

No publications provided

Responsible Party: Ravi Kalhan, Assistant Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00741767     History of Changes
Other Study ID Numbers: 3582
Study First Received: August 22, 2008
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Sleep Disorders
Parasomnias
Lung Diseases, Obstructive
Respiratory Tract Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
 Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on May 16, 2013