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

Stopped early · Phase 4

Conditions studied: COPD, Chronic Bronchitis

In brief

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).

Key facts

Study ID

NCT02416102

Run by

University of Miami

People needed

31

Starts

2016-03-31

Expected to finish

2017-04-03

Last updated by the study team

2020-08-20

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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