Comparing Fluticasone-Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Information source: Penn State University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: fluticasone/salmeterol 250/50 (Drug); placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s): Timothy Craig, DO, Principal Investigator, Affiliation: Penn State University
Overall contact: Cathy Mende, RNP, Phone: 717-531-4513, Email: cmende@hmc.psu.edu
Summary
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.
Clinical Details
Official title: TITLE: Double-Blinded, Double-Dummy, Study Comparing Fluticasone-Salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: daytime somnolence
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
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Cathy Mende, RNP, Phone: 717-531-4513, Email: cmende@hmc.psu.edu
Penn State Universuty, Hershey, Pennsylvania 17033, United States; Not yet recruiting Cathy Mende, RNP, Phone: 717-531-4513, Email: cmende@hmc.psu.edu Timothy Craig, DO, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: August 8, 2008
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