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

Primary Purpose

COPD, Chronic Bronchitis

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Losartan 50 mg

Losartan 100 mg

About this trial

This is an interventional basic science trial for COPD

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Healthy non-smokers

Smokers without COPD

Ex-smokers with COPD

Arm Description

10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.

10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.

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.

Outcomes

Primary Outcome Measures

Change in Nasal Potential Difference (NPD).

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

Secondary Outcome Measures

Change in IL-8 Concentrations

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

Percent Change in TGF-ß mRNA Expression

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

Full Information

NCT ID

NCT02416102

First Posted

January 16, 2015

Last Updated

August 7, 2020

Sponsor

University of Miami

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Flight Attendant Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02416102

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Difficulty in recruitment

Study Start Date

March 31, 2016 (Actual)

Primary Completion Date

April 3, 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Flight Attendant Medical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Bronchitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy non-smokers

Arm Type

Active Comparator

Arm Description

10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.

Arm Title

Smokers without COPD

Arm Type

Experimental

Arm Description

10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.

Arm Title

Ex-smokers with COPD

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Losartan 50 mg

Other Intervention Name(s)

Cozaar

Intervention Description

50 mg Losartan taken orally once daily for 4 consecutive weeks.

Intervention Type

Drug

Intervention Name(s)

Losartan 100 mg

Other Intervention Name(s)

Cozaar

Intervention Description

50 mg Losartan taken orally twice daily for 4 consecutive weeks.

Primary Outcome Measure Information:

Title

Change in Nasal Potential Difference (NPD).

Description

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

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Change in IL-8 Concentrations

Description

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

Time Frame

Baseline, 8 weeks

Title

Percent Change in TGF-ß mRNA Expression

Description

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

Time Frame

Baseline, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rafael Calderon, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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