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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02416102
• Other study ID #: 20140722
• Secondary ID: R01HL133240R01HL
• Status: Terminated
• Phase: Phase 4
• Start date: March 31, 2016
• Est. completion date: April 3, 2017

Study information

• Verified date: August 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD

Intervention

Drug:
• Losartan 50 mg
50 mg Losartan taken orally once daily for 4 consecutive weeks.
• Losartan 100 mg
50 mg Losartan taken orally twice daily for 4 consecutive weeks.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Flight Attendant Medical Research Institute, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Nasal Potential Difference (NPD).	NPD were assessed from nasal cells collected using sterile cytology brushes.	Baseline, 8 weeks
Secondary	Change in IL-8 Concentrations	Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage	Baseline, 8 weeks
Secondary	Percent Change in TGF-ß mRNA Expression	Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.	Baseline, 8 weeks