Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis
Condition: COPD; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Intervention: Losartan 50 mg; Losartan 100 mg
Intervention description: 50 mg Losartan taken orally once daily for 4 consecutive weeks.; 50 mg Losartan taken orally twice daily for 4 consecutive weeks.
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility 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.