Chronic Obstructive Pulmonary DiseasePhase 4DISK-02NCT00974246
The Effect on Depressive Symptoms in ECF Residents With COPD
A Phase 4 study testing Advair diskus in people with Chronic Obstructive Pulmonary Disease and Depression, run by Valley Medical Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Depression
- What is being tested?
- Advair diskus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geriatric Medical Associates
Brooksville, Florida, 34601
Valley Medical Research
Centerville, Ohio, 45459
About this study
Official title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Depression
- Being tested
- Advair diskus
- Keywords
- COPD, Depression, Nursing Home
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advair diskusDrug
Advair diskus 50/250 1 inhalation bid for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| COPD, ECF residents, Advair diskus | Experimental | open label treatment with Advair diskus in COPD patients Receives: Drug: Advair diskus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meenakshi Patel, MD, Valley Medical Research
- Investigators
- Meenakshi Patel, MD, Principal investigator, Valley Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974246
- Sponsor's protocol ID
- DISK-02
- Acronym
- DISK-02
- Status last verified
- Nov 2016
- First submitted
- 8 Sep 2009
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
- ClinicalTrials.gov ID
- NCT00974246
- Acronym / sponsor ID
- DISK-02 / DISK-02
- Conditions
- Chronic Obstructive Pulmonary Disease, Depression
- Keywords
- COPD, Depression, Nursing Home
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Valley Medical ResearchUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 2 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD, ECF residents, Advair diskus | Experimental | Drug: Advair diskusopen label treatment with Advair diskus in COPD patients |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advair diskusAdvair diskus 50/250 1 inhalation bid for 16 weeks | Drug | COPD, ECF residents, Advair diskus |
Primary outcome
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
Time frame: 16 weeks
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.
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.
Time frame: 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.
Pulmonary Function FEC/FVC Ratio at 16 Weeks
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meenakshi Patel, MD principal investigator
Valley Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advair diskus in people with Chronic Obstructive Pulmonary Disease and Depression, run by Valley Medical Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.