COPDPhase 4NCT00720226
Efficacy of Losartan in Preventing Progression of COPD
A Phase 4 study testing Losartan in people with COPD and Emphysema, run by Johns Hopkins University at 1 site in United States.
Trial summary
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Emphysema, Chronic Bronchitis
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with COPD who are either active or former smokers
Who cannot join
- Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21205
About this study
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).
Read the detailed description
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.
- Conditions
- COPD, Emphysema, Chronic Bronchitis, Smoking
- Being tested
- Losartan, Placebo
- Keywords
- COPD, emphysema, angiotensin receptor blocker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
Losartan 100 mg daily
PlaceboDrug
Also called "Sugar pill"
Placebo pill daily
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Losartan 100 mg daily Receives: Drug: Losartan |
| Placebo | Placebo comparator | Placebo 1 pill daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Emphysema on CT Scan
Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.
Measured: Change between baseline and month 12.
Secondary outcomes (1)
Change in FEV1 (L)
Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.
Measured: Measured at Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2014
- Study completionAug 2016
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 COPDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert A. Wise, Johns Hopkins University
- Investigators
- Robert A. Wise, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720226
- Sponsor's protocol ID
- 1P50HL084945
- Other IDs
- 1P50HL084945
- Status last verified
- Mar 2017
- First submitted
- 18 Jul 2008
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Limited dataset available to qualified investigators with data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Losartan in Preventing Progression of COPD
- ClinicalTrials.gov ID
- NCT00720226
- Acronym / sponsor ID
- 1P50HL084945
- Conditions
- COPD, Emphysema, Chronic Bronchitis, Smoking
- Keywords
- COPD, emphysema, angiotensin receptor blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Merck Sharp & Dohme LLC
- Study start
- Jul 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).
Detailed description
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: LosartanLosartan 100 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 pill daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with COPD who are either active or former smokers
Key exclusion criteria (1 listed)
- Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.
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 |
|---|---|---|
| LosartanAlso: CozaarLosartan 100 mg daily | Drug | Losartan |
| PlaceboAlso: "Sugar pill"Placebo pill daily | Drug | Placebo |
Primary outcome
Change in Percent Emphysema on CT Scan
Time frame: Change between baseline and month 12.
Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.
1 secondary outcome
Change in FEV1 (L)
Time frame: Measured at Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Limited dataset available to qualified investigators with data use agreement.
Related trials for COPD
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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.
Robert A. Wise, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan in people with COPD and Emphysema, run by Johns Hopkins University at 1 site 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 1 inclusion and 1 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 25 Apr 2017). 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?
Change in Percent Emphysema on CT Scan (time frame: Change between baseline and month 12.). 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 25 Apr 2017.