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| 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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD |
| 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 |
|---|---|
|
COPD, ECF residents, Advair diskus: Experimental
open label treatment with Advair diskus in COPD patients
|
Drug: Advair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Meenakshi Patel, MD | 937-208-8298 | mpatelmd@ymail.com |
| Contact: Malcolm R Fraser, MD | 727 510 2785 | mf@baygeriatrics.com |
| United States, Florida | |
| Geriatric Medical Associates | |
| Brooksville, Florida, United States, 34601 | |
| United States, Ohio | |
| Valley Medical Research | |
| Centerville, Ohio, United States, 45459 | |
| Principal Investigator: | Meenakshi Patel, MD | Valley Medical Research |
More Information
| Responsible Party: | Valley Medical Research ( Meenakshi Patel, MD ) |
| Study ID Numbers: | DISK-02 |
| Study First Received: | September 8, 2009 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00974246 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
COPD Depression Nursing Home |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents Mental Disorders Therapeutic Uses Fluticasone |
Dermatologic Agents Salmeterol Depression Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Depressive Disorder Pharmacologic Actions Behavioral Symptoms Autonomic Agents Lung Diseases Mood Disorders Peripheral Nervous System Agents Bronchodilator Agents |
