Comparing Fluticasone-Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Penn State University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00731770
First received: August 7, 2008
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

Fluticasone, an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to significantly improve FEV1 and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).

Previous research of subjects from our group with asthma has shown salmeterol to be associated with sustained improvements in morning PEF, protection from nighttime lung function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999). This study has not been performed in patients with COPD nor has the effect of salmeterol with fluticasone on sleep quality been assessed.

AIM: The aim of this study is to determine the effect of fluticasone/salmeterol on sleep quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on sleep.

The hypothesis is that there would be a significant improvement in sleep quality when patients are placed on fluticasone/salmeterol as compared to placebo.


Condition Intervention Phase
COPD
Drug: fluticasone/salmeterol 250/50
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: TITLE: Double-Blinded, Double-Dummy, Study Comparing Fluticasone-Salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • The aim of this study is to determine the effect of fluticasone/salmeterol on sleep quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on sleep. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • daytime somnolence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo diskus 1 puff bid
Drug: placebo
placebo diskus 1 puff bid
Active Comparator: active
advair 250 1 puff bid
Drug: fluticasone/salmeterol 250/50
250/50 1 puff bid
Other Name: Advair 250 bid

Detailed Description:

RATIONALE:

Chronic obstructive pulmonary disease (COPD) is a term that describes a disease state in which there is chronic irreversible airflow limitation. It has been well documented that patients with COPD have disturbed sleep. Certain published reports suggest that more than 50% of COPD patients have sleep complaints (George et al., Drugs, 2003). These patients are found to have sleep onset latency and poor sleep maintenance. While their sleep disturbance may be explained in part by side effects of medications, it could also be a result of nocturnal gas exchange abnormalities (Knutty 2004). In COPD there is worsening hypoxemia and hypercapnia during sleep, particularly REM sleep, and sleep disturbance seems to be worse with more severe COPD. It is commonly believed that optimizing medical management of the disease is important in improving the sleep quality of these patients and thus leading to improved quality of life.

Fluticasone, an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to significantly improve FEV1 and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).

Previous research of subjects from our group with asthma has shown salmeterol to be associated with sustained improvements in morning PEF, protection from nighttime lung function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999). This study has not been performed in patients with COPD nor has the effect of salmeterol with fluticasone on sleep quality been assessed.

AIM:

The aim of this study is to determine the effect of fluticasone/salmeterol on sleep quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on sleep.

The hypothesis is that there would be a significant improvement in sleep quality when patients are placed on fluticasone/salmeterol as compared to placebo.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with moderate to severe COPD as per GOLD criteria
  2. Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history
  3. Age 45 to 75 years, male or female
  4. FEV1 below 80% of predicted using CRAPO
  5. FEV1/FVC < 70% predicted
  6. Past or present tobacco smoker
  7. Female patients must be postmenopausal for 1 year or be willing to use birth control or abstain from sex.

Exclusion Criteria:

  1. Asthma
  2. Use of oral or injectable corticosteroids within 2 months
  3. Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
  4. Lung or heart disease except for COPD
  5. Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
  6. Obesity defined as BMI >30kg/m2
  7. Inability to tolerate or history of allergy to long acting beta agonist or inhaled corticosteroid therapy.
  8. Inability to complete a 2 week run-in with albuterol prn as only therapy
  9. Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and other medications known to affect daytime somnolence or sleep quality
  10. Excessive use of alcohol or use of "recreational drugs"
  11. Use of narcotics, sleep aids, sedatives or sedating antihistamines.
  12. Night shift workers
  13. Women who are breast feeding or pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731770

Contacts
Contact: Cathy Mende, RNP 717-531-4513 cmende@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Universuty Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Cathy Mende, RNP    717-531-4513    cmende@hmc.psu.edu   
Principal Investigator: Timothy Craig, DO         
Sponsors and Collaborators
Penn State University
GlaxoSmithKline
Investigators
Principal Investigator: Timothy Craig, DO Penn State University
  More Information

No publications provided

Responsible Party: Timothy Craig, Penn State University
ClinicalTrials.gov Identifier: NCT00731770     History of Changes
Other Study ID Numbers: IRB 29024
Study First Received: August 7, 2008
Last Updated: August 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
COPD
sleep
daytime somnolence

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
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
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 28, 2014