Title
The Effect on Depressive Symptoms in ECF Residents With COPD
The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
Phase
Phase 4Lead Sponsor
Valley Medical ResearchStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Obstructive Pulmonary Disease DepressionIntervention/Treatment
fluticasone salmeterol ...Study Participants
30The 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.
We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The numbers are not necessarily adequate to achieve statistical difference-we are looking for trends.
Advair diskus 50/250 1 inhalation bid for 16 weeks
open label treatment with Advair diskus in COPD patients
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
| Event Type | Organ System | Event Term | Adverse Events |
|---|
To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.
The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.
FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.
