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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 October 2020 |
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Main ID: |
EUCTR2010-022042-24-GB |
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Date of registration:
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25/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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24/12/2010 |
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Target sample size:
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32 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022042-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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: 14.1
Level: PT
Classification code 10006445
Term: Bronchiectasis
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Intervention(s)
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Trade Name: Lipitor
Product Name: Atorvastatin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
Other descriptive name: Lipitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary outcome is improvement in cough, assessed by the Leicester cough questionnaire.
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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.
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Secondary Objective: -Can statin therapy given over 3 months cause clinical improvements including reduce number of exacerbations?
-Is statin therapy well tolerated in this patient group? (By assessing side effects and symptom diary card)
- Is there a difference in the pre/post change on placebo compared to active treatment for the following variables:
Health related quality of life (St.Georges Respiratory Questionnaire)
Sputum bacterial load, Sputum inflammatory markers (Myeloperoxidase, Elastase, IL8, TNFalpha,LTB4, C5a),
Spirometry (FEV1 and FVC),
Exercise capacity (incremental shuttle walk test), Neutrophil and macrophage assay( IL8, LTB4, C5a) and C reactive protein
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Secondary ID(s)
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Statin_p.aeruginosa
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 28/10/2010
Contact:
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