Phase 4 N=27 Treatment

The Effect on Depressive Symptoms in ECF Residents With COPD

Chronic Obstructive Pulmonary Disease · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00974246 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Jul 2015

Primary outcome: Primary: To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 — 8.7; 10.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Advair diskus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Valley Medical Research
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0	8.7; 10.8	—
PRIMARY To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.	8.7; 10.8	—
PRIMARY Pulmonary Function FEC/FVC Ratio at 16 Weeks	0.69	—

Summary

The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

Eligibility Criteria

Inclusion Criteria

Adult men and women nursing home residents up to age 95
Stated diagnosis of COPD or FEV1/FVC <0.7 or being treated with an anticholinergic
Presence of depressive symptoms as measured on MDS 3.0 Section D SUM
Free from conditions likely to be fatal within six months
Able to read or understand English
Able and willing to provide informed consent or has a guardian/LAR who can provide informed consent

Exclusion Criteria

Currently pregnant
Unable to read and understand English
Free from conditions likely to be fatal within six months
Enrolled in hospice
New treatment with antidepressant within the last 90 days.
Current or recent use (within the last 90 days) of Advair Diskus
Unwilling or unable to provide informed consent
Expected to be discharged within 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00974246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.