The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD - Full Text View

Sponsor:	Northwestern University
Collaborator:	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

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Sleep Disorders

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair

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
Estimated Study Completion Date:	September 2010
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, MD, MS, Northwestern University
ClinicalTrials.gov Identifier:	NCT00741767 History of Changes
Other Study ID Numbers:	3582
Study First Received:	August 22, 2008
Last Updated:	May 27, 2010
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 February 09, 2012