A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis

Phase 1

• Conditions: The aim of this randomised double blind controlled study to evaluate the efficacy of 6 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis; MedDRA version: 14.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-022040-20-GB
• Lead Sponsor: HS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-21
• Study Completion: 2012-11-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria
1) Confirmed diagnosis of bronchiectasis on High Resolution CT scanning
2) Able to give informed consent
3) Age between 18 and 79 years

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria
1)Patients chronically colonised with Pseudomonas aeruginosa (defined as two or more isolates of Pseudomonas aeruginosa whilst clinically stable in 6 months prior to the study)
2)current smokers or ex-smokers of less than 1 year; >15 pack year history;
3)cystic fibrosis;
4)active allergic bronchopulmonary aspergillosis;
5)active tuberculosis;
6)poorly controlled asthma;
7)pregnancy or breast feeding;
8)known allergy to statins;
9)active malignancy; chronic liver disease; established cardiovascular or cerebrovascular disease;
10)statin use in the last year;
11)patients on long term oral macrolides due to the interaction with statin therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary outcome is improvement in cough, assessed by the Leicester cough questionnaire.;<br> Secondary Objective: The secondary outcomes are<br> - Health related quality of life (St.Georges Respiratory Questionnaire)<br> - Sputum bacterial load<br> - Sputum inflammatory markers (Myeloperoxidase, Elastase, IL-8, TNF-alpha, LTB4, C5a)<br> - Spirometry (FEV1 and FVC)<br> - Exercise capacity (incremental shuttle walk test)<br> -Neutrophil and Macrophge assay (IL-8, C5a, LT-B4)<br> ;Primary end point(s): The primary endpoint is an improvement in cough by 1.3 units Leicester Cough Questionnaire (the minimum clinical important difference) at 6 months in comparison to baseline.