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

October 5, 2015 updated by: Ravi Kalhan, Northwestern University

The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Advair Diskus
Other: 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 Names:
  • Advair Diskus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in subjective measures of sleep quality
Time Frame: 16 weeks
16 weeks
Changes in objective measures of sleep and daytime cognitive function
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in lung hyperinflation and systemic inflammation
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Ravi Kalhan, MD, MS, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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