Trial Outcomes & Findings for The Effect on Depressive Symptoms in ECF Residents With COPD (NCT NCT00974246)

Last Updated: 2016-12-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

16 weeks

Results posted on

2016-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Study Population: The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio \<0.7 or (3) in treatment with anticholinergic drugs.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect on Depressive Symptoms in ECF Residents With COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Characteristics n=27 Participants Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio \<0.7 or in treatment with anticholinergic drugs.
Age, Continuous	79.7 years STANDARD_DEVIATION 12.4 • n=93 Participants
Gender Female	20 Participants n=93 Participants
Gender Male	7 Participants n=93 Participants
Region of Enrollment United States	27 participants n=93 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Nursing Home Residents With COPD n=27 Participants The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
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 Cornell Depression Scale	8.7 units on a scale Interval 2.0 to 21.0
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 Section D SUM of the Minimum Data Set 3.0	10.8 units on a scale Interval 5.0 to 21.0

PRIMARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Nursing Home Residents With COPD n=27 Participants The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
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. Cornell Depression Scale	8.7 units on a scale Standard Deviation 5.0
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. Section D SUM of the Minimum Data Set	10.8 units on a scale Standard Deviation 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nursing Home Residents With COPD n=27 Participants The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
Pulmonary Function FEC/FVC Ratio at 16 Weeks	0.69 ratio Standard Deviation 0.13

Adverse Events

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adverse Events n=27 participants at risk All enrolled subjects.
Psychiatric disorders Mental Status Change	3.7% 1/27 • Number of events 1
Psychiatric disorders Increased Agitation with Combative Behaviors	3.7% 1/27 • Number of events 1
Musculoskeletal and connective tissue disorders Left Above the Knee Amputation	3.7% 1/27 • Number of events 1

Other adverse events

Other adverse events
Measure	Adverse Events n=27 participants at risk All enrolled subjects.
Musculoskeletal and connective tissue disorders Fall	40.7% 11/27 • Number of events 22
Metabolism and nutrition disorders Vitamin D Deficiency	22.2% 6/27 • Number of events 6
Blood and lymphatic system disorders Bilateral Lower Extremity Edema	7.4% 2/27 • Number of events 2
Respiratory, thoracic and mediastinal disorders Productive Cough	7.4% 2/27 • Number of events 2
Skin and subcutaneous tissue disorders Pruitis	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Right Hip Pain	7.4% 2/27 • Number of events 2
Psychiatric disorders Increased Aggression	7.4% 2/27 • Number of events 2
Psychiatric disorders Increased Restlessness	11.1% 3/27 • Number of events 3
Renal and urinary disorders Urinary Tract Infection	25.9% 7/27 • Number of events 7
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	14.8% 4/27 • Number of events 4
Renal and urinary disorders Urinary Incontinence	7.4% 2/27 • Number of events 2
Ear and labyrinth disorders Dizziness	11.1% 3/27 • Number of events 3
Skin and subcutaneous tissue disorders Cellulitis	11.1% 3/27 • Number of events 3
General disorders Headache	7.4% 2/27 • Number of events 2
Gastrointestinal disorders Loose stool	14.8% 4/27 • Number of events 4
Blood and lymphatic system disorders Anemia	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Osteoporosis	7.4% 2/27 • Number of events 2
Blood and lymphatic system disorders Hypotension	7.4% 2/27 • Number of events 2
Eye disorders Conjunctivitis	7.4% 2/27 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumonia	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Leg Pain	7.4% 2/27 • Number of events 2

Additional Information

Meenakshi Patel, MD

Valley Medical Research

Phone: 937-208-8298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place