The Effect on Depressive Symptoms in ECF Residents With COPD

NCT00974246 | Completed Phase 4 Results

• 1 other identifier: DISK-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Depression

Keywords

COPD; Depression; Nursing Home

Outcome Measures

Primary Outcomes (3)

• To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0

  The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.

  16 weeks

• To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.

  FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.

  16 weeks

• Pulmonary Function FEC/FVC Ratio at 16 Weeks

  To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.

  16 weeks

Study Arms (1)

COPD, ECF residents, Advair diskus

EXPERIMENTAL

open label treatment with Advair diskus in COPD patients

Drug: Advair diskus

Interventions

Advair diskus DRUG

Advair diskus 50/250 1 inhalation bid for 16 weeks

COPD, ECF residents, Advair diskus

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valley Medical Research: lead

Study Sites (2)

Geriatric Medical Associates

Brooksville, Florida, 34601, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Depression

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Meenakshi Patel, MD
• Organization: Valley Medical Research

mpatelmd@ymail.com

937-208-8298

Study Officials

• Meenakshi Patel, MD

  Valley Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Meenakshi Patel, MD

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 10, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 28, 2016
• Results First Posted: July 2, 2015

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)