A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas

Phase 1

• Conditions: The aim of this randomized double blind controlled study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis.; MedDRA version: 14.1Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-022042-24-GB
• Lead Sponsor: HS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-25
• Study Completion: 2017-05-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1) Confirmed diagnosis of bronchiectasis on High Resolution CT scanning
2)Patients colonised with Pseudomonas Aeruginosa
3) Able to give informed consent
4)Age between 18-79 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

1)current smokers or ex-smokers of less than 1 year; >15 pack year history;
2)cystic fibrosis;
3)active allergic bronchopulmonary aspergillosis;
4)active tuberculosis;
5)poorly controlled asthma;
6)pregnancy or breast feeding( we will ask if patient is pregnant or planning to become pregnant)
7)known allergy to statins;
8)active malignancy; chronic liver disease; established cardiovascular or cerebrovascular disease;
9)statin use in the last year;
10)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.;Secondary Objective: -Can statin therapy given over 3 months cause clinical improvements including reduce number of exacerbations?<br>-Is statin therapy well tolerated in this patient group? (By assessing side effects and symptom diary card)<br>- Is there a difference in the pre/post change on placebo compared to active treatment for the following variables: <br>Health related quality of life (St.Georges Respiratory Questionnaire)<br>Sputum bacterial load, Sputum inflammatory markers (Myeloperoxidase, Elastase, IL8, TNFalpha,LTB4, C5a), <br>Spirometry (FEV1 and FVC), <br>Exercise capacity (incremental shuttle walk test), Neutrophil and macrophage assay( IL8, LTB4, C5a) and C reactive protein<br>;Primary end point(s): The primary outcome is to determine whether there is a difference in the pre/post change observed on placebo compared to active treatment.