Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Lovastatin as a Potential Modulator of Apoptosis in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700921
• Other study ID #: NJMRC HS-2163
• Secondary ID: NIH grant #HL088
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: November 2012

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).

Description:

The impact of lovastatin, 40mg by mouth once daily on biological and clinical outcomes will be evaluated in an exploratory 16-week comparative treatment efficacy trial in 44 adult former smokers with established COPD of moderate severity. This trial employs a longitudinal randomized, parallel-arm, double-blind, placebo-controlled design using biomarkers of airway inflammation as the primary outcomes of interest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Adult (=45 years) former smokers with = 10 pack-years of cigarette smoking

2. FEV1/FVC ratio < 70%

3. Post-bronchodilator FEV1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only

4. DLco/VA < 80% predicted

5. Ability to perform and adhere to study protocol

6. ability to provide informed consent.

Exclusion Criteria:

1. Asthma or other comorbid lung disease,

2. Hypoxemia (PaO2 < 55 mmHg or SpO2 < 88% on room air), if undergoing bronchoscopy

3. Exacerbation of COPD within the last 6 weeks

4. Upper or lower respiratory tract infection within the last 6 weeks

5. Current smoking

6. Significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months

7. Current use of HMG-coA-reductase inhibitors

8. Current use of inhaled corticosteroid

9. Concurrent use of other Cyp3A4 (isoform of cytochrome P450) inhibitors

10. History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)

11. For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Lovastatin
40mg po once daily
• Placebo
One capsule, once daily

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.		5 years
Secondary	To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life.		5 years