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

This study has been completed.
Information provided by (Responsible Party):
Meenakshi Patel, MD, Valley Medical Research Identifier:
First received: September 8, 2009
Last updated: December 19, 2012
Last verified: December 2012

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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Advair diskus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Resource links provided by NLM:

Further study details as provided by Valley Medical Research:

Primary Outcome Measures:
  • To determine the effect of treating COPD patients with Advair diskus for 16 weeks on the Cornell depression scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of treatment with Advair diskus on spirometry measure in nursing home residents with COPD [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD, ECF residents, Advair diskus
open label treatment with Advair diskus in COPD patients
Drug: Advair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks

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.


Ages Eligible for Study:   18 Years to 94 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00974246

United States, Florida
Geriatric Medical Associates
Brooksville, Florida, United States, 34601
United States, Ohio
Valley Medical Research
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
Valley Medical Research
Principal Investigator: Meenakshi Patel, MD Valley Medical Research
  More Information

No publications provided

Responsible Party: Meenakshi Patel, MD, Valley Medical Research Identifier: NCT00974246     History of Changes
Other Study ID Numbers: DISK-02
Study First Received: September 8, 2009
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Medical Research:
Nursing Home

Additional relevant MeSH terms:
Depressive Disorder
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Lung Diseases
Mental Disorders
Mood Disorders
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses processed this record on May 21, 2015