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The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With Chronic Obstructive Pulmonary Disease (COPD)

Information source: Valley Medical Research
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease; Depression

Intervention: Advair diskus (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Valley Medical Research

Official(s) and/or principal investigator(s):
Meenakshi Patel, MD, Principal Investigator, Affiliation: Valley Medical Research

Overall contact:
Meenakshi Patel, MD, Phone: 937-208-8298, Email: mpatelmd@ymail.com

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.

Clinical Details

Official title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the effect of treating COPD patients with Advair diskus for 16 weeks on the Cornell depression scale

Secondary outcome: To determine the effect of treatment with Advair diskus on spirometry measure in nursing home residents with COPD

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 94 Years. Gender(s): Both.

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

Locations and Contacts

Meenakshi Patel, MD, Phone: 937-208-8298, Email: mpatelmd@ymail.com

Geriatric Medical Associates, Brooksville, Florida 34601, United States

Valley Medical Research, Centerville, Ohio 45459, United States

Additional Information

Starting date: October 2009
Last updated: September 9, 2009

Page last updated: December 08, 2011

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