The Effect on Depressive Symptoms in ECF Residents With COPD (DISK-02)

Valley Medical Research

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease; Depression

Treatments: Drug: Advair diskus

Study type: Interventional

Funder types: Other

Identifiers

NCT00974246

DISK-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 94 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

COPD, ECF residents, Advair diskus

Experimental group

Description:

open label treatment with Advair diskus in COPD patients

Treatment:

Drug: Advair diskus