TerminatedNCT02416102Updated Aug 20, 2020Results posted

Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis

A Phase 4 interventional study of Losartan 50 mg and Losartan 100 mg in COPD and Chronic Bronchitis, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by University of Miami · Phase 4, Interventional, and Basic science

Why this study was terminated

Difficulty in recruitment

Phase: Phase 4
Study type: Interventional
Enrollment: 31
Allocation: Non-randomized
Ages: 35 Years to 75 Years
Sex: All

Study 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).

Conditions studied

COPD
Chronic Bronchitis

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In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 31 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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
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.

Study design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Active comparator
Healthy non-smokers
10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.
Drug: Losartan 50 mg · Drug: Losartan 100 mg
Experimental
Smokers without COPD
10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.
Drug: Losartan 50 mg · Drug: Losartan 100 mg
Experimental
Ex-smokers with COPD
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.
Drug: Losartan 50 mg · Drug: Losartan 100 mg

Interventions

DrugLosartan 50 mg
50 mg Losartan taken orally once daily for 4 consecutive weeks.
Also known as: Cozaar
DrugLosartan 100 mg
50 mg Losartan taken orally twice daily for 4 consecutive weeks.
Also known as: Cozaar

What researchers measure

Primary outcomes

Change in Nasal Potential Difference (NPD).
NPD were assessed from nasal cells collected using sterile cytology brushes.
Time frame: Baseline, 8 weeks

Secondary outcomes

Change in IL-8 Concentrations
Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage
Time frame: 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.
Time frame: Baseline, 8 weeks

Results

Posted Aug 20, 2020

Participant flow

Participant flow — Overall Study
Milestone	Healthy Non-smokers	Smokers Without COPD
Started	16	15
Completed	7	7
Not completed	9	8

Outcome measures

PrimaryChange in Nasal Potential Difference (NPD).

NPD were assessed from nasal cells collected using sterile cytology brushes.

Time frame:: Baseline, 8 weeks

No measurements were reported for this outcome.

SecondaryChange in IL-8 Concentrations

Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage

Time frame:: Baseline, 8 weeks
Reported as:: Mean · pg/mL

Change in IL-8 Concentrations
pg/mL	Healthy Non-smokers	Smokers Without COPD	Ex-smokers With COPD
Change in IL-8 Concentrations	2867 ± 1685	4676 ± 1948	—

SecondaryPercent Change in TGF-ß mRNA Expression

Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.

Time frame:: Baseline, 8 weeks
Reported as:: Mean · percentage change in mRNA expression

Percent Change in TGF-ß mRNA Expression
percentage change in mRNA expression	Healthy Non-smokers	Smokers Without COPD	Ex-smokers With COPD
Percent Change in TGF-ß mRNA Expression	-51 ± 31	-23 ± 70	—

Adverse events

Collected over 8 Weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Healthy Non-smokers	0/16 (0%)	0/16 (0%)	0/16 (0%)
Smokers Without COPD	0/15 (0%)	0/15 (0%)	0/15 (0%)
Ex-smokers With COPD	—	—	—

Baseline characteristics

There was a difficulty in recruitment ex-smokers with COPD prior to study termination

Age, Categorical
Age, Categorical(Participants)	Healthy Non-smokers	Smokers Without COPD	Total
<=18 years	0	0	0
Between 18 and 65 years	15	15	30
>=65 years	1	0	1

Sex: Female, Male
Sex: Female, Male(Participants)	Healthy Non-smokers	Smokers Without COPD	Ex-smokers With COPD	Total
Female	13	8	0	21
Male	3	7	0	10

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Healthy Non-smokers	Smokers Without COPD	Total
Hispanic or Latino	13	13	26
Not Hispanic or Latino	3	2	5
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Healthy Non-smokers	Smokers Without COPD	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	2	2
White	13	9	22
More than one race	1	1	2
Unknown or Not Reported	2	3	5

Study locations

1 site

University of Miami
Miami, Florida 33136, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02416102
Lead sponsor: University of Miami
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Flight Attendant Medical Research Institute
Responsible party: Rafael Calderon Candelario (Assistant Professor, University of Miami) — Principal investigator
First posted: Apr 14, 2015
Start date: Mar 31, 2016
Primary completion: Apr 3, 2017
Completion: Apr 3, 2017
Results posted: Aug 20, 2020
Last update: Aug 20, 2020

Study contacts

Rafael Calderon, MD

principal investigator · University of Miami

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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