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

NCT00741767 | Withdrawn

• 1 other identifier: 3582
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease; Sleep Disorders

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Sleep; Sleep quality; Lung hyperinflation

Outcome Measures

Primary Outcomes (2)

• Changes in subjective measures of sleep quality

  16 weeks

• Changes in objective measures of sleep and daytime cognitive function

  16 weeks

Secondary Outcomes (1)

• Changes in lung hyperinflation and systemic inflammation

  16 weeks

Study Arms (2)

Salmeterol-fluticasone

OTHER

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

Placebo

OTHER

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

Interventions

salmeterol-fluticasone DRUG

250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily

Also known as: Advair Diskus

Placebo; Salmeterol-fluticasone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Do you have trouble falling asleep?
• Do you have trouble staying asleep?
• Do you not get enough sleep?
• Do you wake up too early and not be able to get back to sleep?
• Do you fall asleep during the day?

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ravi Kalhan, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2012
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (1)