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

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Chronic Bronchitis; COPD

Treatments: Drug: Losartan 100 mg; Drug: Losartan 50 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02416102

R01HL139365 (U.S. NIH Grant/Contract)

R01HL133240 (U.S. NIH Grant/Contract)

20140722

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Fulfill one of the group definitions above
2. Age between 35 and 75 years old
3. Clinical diagnosis of chronic bronchitis, defined as productive cough for at least 3 months per year for at least two consecutive years
4. Stable maintenance of all current medication therapy for 3 months, including ARBs for treated groups

Exclusion criteria

1. Current therapy with Angiotensin-converting-enzyme (ACE) inhibitor,or Intolerance to Angiotensin II receptor blockers (ARB)
2. Women of child bearing potential
3. Current use of nonsteroidal antiinflammatory drugs or potassium supplementation, treatment with aliskiren, anticoagulation
4. COPD exacerbation requiring treatment within 6 weeks of the screening visit
5. Oral corticosteroid use within 6 weeks of the screening visit
6. 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
7. Untreated arterial hypertension (systolic blood pressure >140 mm Hg, diastolic blood pressure > 90 mm Hg)
8. Ability to understand and willingness to sign consent documents
9. Blood pressure less than 100 mm Hg systolic or 70 mm Hg diastolic while standing at the screening visit
10. 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
11. History of renal artery stenosis
12. 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)
13. History of pulmonary malignancies, and any other malignancies in the last 5 years
14. History of thoracic surgery.
15. Acute pulmonary exacerbation within 6 weeks from the Screening Visit.
16. Subjects with no airflow obstruction by spirometry but with a decrease in diffusing capacity of lung for carbon monoxide(DLco) possibly indicating emphysema.
17. Significant exposure to environmental tobacco smoke or atmospheric or occupational pollutants
18. Urine pregnancy positive test at the Screening Visit.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Healthy non-smokers

Active Comparator group

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.

Treatment:

Drug: Losartan 50 mg

Drug: Losartan 100 mg

Smokers without COPD

Experimental group

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.

Treatment:

Drug: Losartan 50 mg

Drug: Losartan 100 mg

Ex-smokers with COPD

Experimental group

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.

Treatment:

Drug: Losartan 50 mg

Drug: Losartan 100 mg