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

The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With Chronic Obstructive Pulmonary Disease (COPD) (DISK-02)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Valley Medical Research. Recruitment status was Not yet recruiting

First Received on September 8, 2009. Last Updated on September 9, 2009 History of Changes

Sponsor:	Valley Medical Research
Information provided by:	Valley Medical Research
ClinicalTrials.gov Identifier:	NCT00974246

Purpose

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 Depression	Drug: Advair diskus	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Depression Nursing Homes

Drug Information available for: Fluticasone, salmeterol drug combination

U.S. FDA Resources

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 ]

Estimated Enrollment:	35
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974246

Contacts

Contact: Meenakshi Patel, MD	937-208-8298	mpatelmd@ymail.com
Contact: Malcolm R Fraser, MD	727 510 2785	mf@baygeriatrics.com

Locations

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

Investigators

Principal Investigator:

Meenakshi Patel, MD

Valley Medical Research

More Information

No publications provided

Responsible Party:	Meenakshi Patel, MD, Valley Medical Research
ClinicalTrials.gov Identifier:	NCT00974246 History of Changes
Other Study ID Numbers:	DISK-02
Study First Received:	September 8, 2009
Last Updated:	September 9, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Valley Medical Research:

COPD
Depression
Nursing Home

Additional relevant MeSH terms:

Depression
Depressive Disorder
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Albuterol
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 24, 2012