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

NCT00731770 | Completed Phase 4 Results DMC

• 1 other identifier: IRB 29024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Fluticasone (Advair), 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 forced expiratory volume (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 peak expiratory flow (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.

Conditions

COPD

Keywords

COPD; sleep; daytime somnolence

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Daytime Somnolence

  1 year

Study Arms (2)

Placebo, then Advair 250- matched

PLACEBO COMPARATOR

1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.

Drug: Advair 250; Drug: Placebo- matched

Advair 250, then Placebo- matched

ACTIVE COMPARATOR

1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.

Drug: Placebo; Drug: Advair 250 - matched

Interventions

Advair 250 DRUG

1 puff bid inhaled

Also known as: fluticasone/salmeterol 250/50

Placebo, then Advair 250- matched

Placebo- matched DRUG

1 puff bid inhaled

Placebo, then Advair 250- matched

Placebo DRUG

Placebo 1 puff bid inhaled

Advair 250, then Placebo- matched

Advair 250 - matched DRUG

i puff bid inhaled

Also known as: fluticasone/salmeterol 250/50

Advair 250, then Placebo- matched

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Asthma
• Use of oral or injectable corticosteroids within 2 months
• Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
• Lung or heart disease except for COPD
• Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
• Obesity defined as BMI \>30kg/m2
• Inability to tolerate or history of allergy to long acting beta agonist or inhaled corticosteroid therapy.
• Inability to complete a 2 week run-in with albuterol prn as only therapy
• Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and other medications known to affect daytime somnolence or sleep quality
• Excessive use of alcohol or use of "recreational drugs"
• Use of narcotics, sleep aids, sedatives or sedating antihistamines.
• Night shift workers
• Women who are breast feeding or pregnant.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Penn State Universuty

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disorders of Excessive Somnolence

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.

Results Point of Contact

• Title: Erin Banta
• Organization: Penn State University

ebanta@hmc.psu.edu

717-531-6525

Study Officials

• Timothy Craig, DO

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Timothy Craig, D.O.

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)