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

August 7, 2008
August 8, 2008
September 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00731770 on ClinicalTrials.gov Archive Site
daytime somnolence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparing Fluticasone-Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
TITLE: Double-Blinded, Double-Dummy, Study Comparing Fluticasone-Salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
COPD
  • Drug: fluticasone/salmeterol 250/50
    250/50 1 puff bid
    Other Name: Advair 250 bid
  • Drug: placebo
    placebo diskus 1 puff bid
  • Placebo Comparator: placebo
    placebo diskus 1 puff bid
    Intervention: Drug: placebo
  • Active Comparator: active
    advair 250 1 puff bid
    Intervention: Drug: fluticasone/salmeterol 250/50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
45 Years to 75 Years
No
Contact: Cathy Mende, RNP 717-531-4513 cmende@hmc.psu.edu
United States
 
NCT00731770
IRB 29024
No
Timothy Craig, Penn State University
Penn State University
GlaxoSmithKline
Principal Investigator: Timothy Craig, DO Penn State University
Penn State University
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP