COPDPhase 4NCT02416102
Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis
A Phase 4 study testing Losartan 50 mg and Losartan 100 mg in people with COPD and Chronic Bronchitis, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Chronic Bronchitis
- What is being tested?
- Losartan 50 mg and Losartan 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2016to 3 Apr 2017
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfill one of the group definitions above
- Age between 35 and 75 years old
- Clinical diagnosis of chronic bronchitis, defined as productive cough for at least 3 months per year for at least two consecutive years
- Stable maintenance of all current medication therapy for 3 months, including ARBs for treated groups
Who cannot join
- Current therapy with Angiotensin-converting-enzyme (ACE) inhibitor,or Intolerance to Angiotensin II receptor blockers (ARB)
- Women of child bearing potential
- Current use of nonsteroidal antiinflammatory drugs or potassium supplementation, treatment with aliskiren, anticoagulation
- COPD exacerbation requiring treatment within 6 weeks of the screening visit
- Oral corticosteroid use within 6 weeks of the screening visit
- Significant hypoxemia (oxygen saturation <90% on room air), chronic respiratory failure by history (pCO2 > 45 mmHg) and forced expiratory volume in 1 second (FEV1) below 40%, clinical evidence of cor pulmonale
Show all 18Show fewer
- Untreated arterial hypertension (systolic blood pressure >140 mm Hg, diastolic blood pressure > 90 mm Hg)
- Ability to understand and willingness to sign consent documents
- Blood pressure less than 100 mm Hg systolic or 70 mm Hg diastolic while standing at the screening visit
- Cardiac, renal, hepatic (LFTs > 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are at the discretion of the investigator, to interfere with participation in study
- History of renal artery stenosis
- Concomitant airway disorders other than COPD and chronic bronchitis, such as bronchiectasis and asthma (history and reversible airflow obstruction by American Thoracic Society (ATS) criteria)
- History of pulmonary malignancies, and any other malignancies in the last 5 years
- History of thoracic surgery.
- Acute pulmonary exacerbation within 6 weeks from the Screening Visit.
- Subjects with no airflow obstruction by spirometry but with a decrease in diffusing capacity of lung for carbon monoxide(DLco) possibly indicating emphysema.
- Significant exposure to environmental tobacco smoke or atmospheric or occupational pollutants
- Urine pregnancy positive test at the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD, Chronic Bronchitis
- Being tested
- Losartan 50 mg, Losartan 100 mg
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan 50 mgDrug
Also called Cozaar
50 mg Losartan taken orally once daily for 4 consecutive weeks.
Losartan 100 mgDrug
Also called Cozaar
50 mg Losartan taken orally twice daily for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Healthy non-smokers | Active comparator | 10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. Receives: Drug: Losartan 50 mg; Drug: Losartan 100 mg |
| Smokers without COPD | Experimental | 10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. Receives: Drug: Losartan 50 mg; Drug: Losartan 100 mg |
| Ex-smokers with COPD | Experimental | 10 ex-smokers with COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. Receives: Drug: Losartan 50 mg; Drug: Losartan 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Potential Difference (NPD).
NPD were assessed from nasal cells collected using sterile cytology brushes.
Measured: Baseline, 8 weeks
Secondary outcomes (2)
Change in IL-8 Concentrations
Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage
Measured: Baseline, 8 weeks
Percent Change in TGF-ß mRNA Expression
Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start31 Mar 2016
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Why it stopped: Difficulty in recruitment
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 University of MiamiThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Flight Attendant Medical Research Institute
- Responsible party
- Principal investigator, Rafael Calderon Candelario, University of Miami
- Investigators
- Rafael Calderon, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416102
- Sponsor's protocol ID
- 20140722
- Other IDs
- R01HL133240, R01HL139365
- Status last verified
- Aug 2020
- First submitted
- 16 Jan 2015
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT02416102
- Acronym / sponsor ID
- 20140722
- Conditions
- COPD, Chronic Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Flight Attendant Medical Research Institute
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 20 Aug 2020
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 evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy non-smokers | Active comparator | Drug: Losartan 50 mg, Drug: Losartan 100 mg10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. |
| Smokers without COPD | Experimental | Drug: Losartan 50 mg, Drug: Losartan 100 mg10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. |
| Ex-smokers with COPD | Experimental | Drug: Losartan 50 mg, Drug: Losartan 100 mg10 ex-smokers with COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfill one of the group definitions above
- Age between 35 and 75 years old
- Clinical diagnosis of chronic bronchitis, defined as productive cough for at least 3 months per year for at least two consecutive years
- Stable maintenance of all current medication therapy for 3 months, including ARBs for treated groups
Key exclusion criteria (18 listed)
- Current therapy with Angiotensin-converting-enzyme (ACE) inhibitor,or Intolerance to Angiotensin II receptor blockers (ARB)
- Women of child bearing potential
- Current use of nonsteroidal antiinflammatory drugs or potassium supplementation, treatment with aliskiren, anticoagulation
- COPD exacerbation requiring treatment within 6 weeks of the screening visit
- Oral corticosteroid use within 6 weeks of the screening visit
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 |
|---|---|---|
| Losartan 50 mgAlso: Cozaar50 mg Losartan taken orally once daily for 4 consecutive weeks. | Drug | Ex-smokers with COPD, Healthy non-smokers, Smokers without COPD |
| Losartan 100 mgAlso: Cozaar50 mg Losartan taken orally twice daily for 4 consecutive weeks. | Drug | Ex-smokers with COPD, Healthy non-smokers, Smokers without COPD |
Primary outcome
Change in Nasal Potential Difference (NPD).
Time frame: Baseline, 8 weeks
NPD were assessed from nasal cells collected using sterile cytology brushes.
2 secondary outcomes
Change in IL-8 Concentrations
Time frame: Baseline, 8 weeks
Percent Change in TGF-ß mRNA Expression
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Rafael Calderon, MD principal investigator
University of Miami
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 50 mg and Losartan 100 mg in people with COPD and Chronic Bronchitis, run by University of Miami 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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 20 Aug 2020. 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. 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 20 Aug 2020). 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 Nasal Potential Difference (NPD). (time frame: Baseline, 8 weeks). 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 20 Aug 2020.