Effect of Symbicort on Sleep Quality in Patients With Emphysema

Emphysema Clinical Trial

Official title:

Effect of Symbicort on Sleep Quality in Patients With Emphysema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01602523
• Other study ID #: 13383
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 23, 2012
• Last updated: December 6, 2012
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: December 2012
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Moderate to severe emphysema (GOLD stages 2 and 3)

Exclusion Criteria:

• Use of supplemental oxygen,

• A recent COPD exacerbation within the past 4 weeks.

• A previous diagnosis of obstructive sleep apnea

• A known urinary outflow obstruction,

• Glaucoma

• History of an allergic reaction to one of the study medications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Poor Sleep Quality
• Pulmonary Emphysema

Intervention

Drug:
• Budesonide/formoterol
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
• Placebo
Placebo inhaler once daily 28 days

Locations

Country	Name	City	State
United States	Temple Lung Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the objective assessment of sleep quality.	Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.	28 days	No
Secondary	Secondary outcome includes assessment of nocturnal oxygenation.	Nocturnal oxygenation will be measured by pulse oximetry.	28 days	No
Secondary	Secondary outcome is the subjective assessment of sleep quality.	Quality of life will be assessed by SF-36 and SGRQ-C scores.	28 days	No
Secondary	Secondary outcome includes assessment respiratory mechanics/function.	Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.	28 days	No
Secondary	Secondary outcome includes assessment of overall quality of life.	Quality of life will be assessed by SF(short form)-36 and SGRQ-C(ST George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease patients)scores.	28 days	No