Effect of Symbicort on Sleep Quality in Patients With Emphysema
|ClinicalTrials.gov Identifier: NCT01602523|
Recruitment Status : Unknown
Verified December 2012 by Samuel Krachman, Temple University.
Recruitment status was: Active, not recruiting
First Posted : May 21, 2012
Last Update Posted : December 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Emphysema Poor Sleep Quality||Drug: Budesonide/formoterol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Symbicort on Sleep Quality in Patients With Emphysema|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||August 2014|
Active Comparator: budesonide/formoterol
budesonide/formoterol 160/4.5 mcg (Symbicort)
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Other Name: Symbicort
Placebo Comparator: Placebo
Placebo inhaler once daily 28 days
- The primary outcome is the objective assessment of sleep quality. [ Time Frame: 28 days ]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.
- Secondary outcome includes assessment of nocturnal oxygenation. [ Time Frame: 28 days ]Nocturnal oxygenation will be measured by pulse oximetry.
- Secondary outcome is the subjective assessment of sleep quality. [ Time Frame: 28 days ]Quality of life will be assessed by SF-36 and SGRQ-C scores.
- Secondary outcome includes assessment respiratory mechanics/function. [ Time Frame: 28 days ]Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
- Secondary outcome includes assessment of overall quality of life. [ Time Frame: 28 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602523
|United States, Pennsylvania|
|Temple Lung Center|
|Philadelphia, Pennsylvania, United States, 19140|