Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa
Recruitment status was Active, not recruiting
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Purpose
Statins are a class of drug used to prevent heart attacks and strokes by lowering blood cholesterol levels. They have also been found to have a beneficial "side effect" of lowering the level of inflammation in the body. This is thought to be one of the reasons they are effective in treating heart attacks and strokes. Laboratory experiments have shown that statins reduce lung inflammation in response to bacteria and this is a promising development for the treatment of chest infections.
Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum production and recurrent chest infections. 2/3 of patients are chronically colonised with bacteria (normally the lungs are sterile) and this leads inflammation in the lung and in the rest of the body.
There are no effective treatments for bronchiectasis other than antibiotics for chest infections. With increasing antibiotic use, there is increasing antibiotic resistance and new treatments for this disease are needed.
The investigators intend to study Atorvastatin in patients with bronchiectasis with colonization with pseudomonas aeruginosa. The investigators will give Atorvastatin to 16 patients with this disease while 16 patients will receive placebo. This will be a crossover study where patients will receive atorvastatin or placebo for 3 months, followed by a statin wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin for 3 months. The investigators will measure inflammation in their lungs and in the rest of their body before and after treatment with atorvastatin. The investigators will also assess their quality of life and number of chest infections over a 7.5 month period.
This pilot study will determine if there is any role for statins are an anti-inflammatory agent in patients with bronchiectasis.
| Condition | Intervention | Phase |
|---|---|---|
|
BRONCHIECTASIS |
Drug: ATORVASTATIN |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas Aeruginosa |
- The primary endpoint of this study is a reduction in cough at 3 months compared to baseline as measured by the Leicester Cough Questionnaire score. [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- pulmonary physiology and assessment of exercise capacity [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- 24 hour sputum volume [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- qualitative and quantitative bacteriology [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- health related quality of life and health care utilisation [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- exacerbation frequency [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- safety of statin therapy [ Time Frame: 7.5 months ] [ Designated as safety issue: Yes ]
- Airways and systemic inflammation [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ATORVASTATIN
Atorvastatin 80mg once daily for 3 months, 1.5 month wash out, then Placebo for 3 months
|
Drug: ATORVASTATIN
80mg once daily for 3 months
|
|
Placebo Comparator: PLACEBO
Placebo 3 months, then washout for 1.5 months, then Atorvastatin 80mg once daily
|
Drug: ATORVASTATIN
80mg once daily for 3 months
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 18-80 will be recruited.
- All will have an established radiological diagnosis of bronchiectasis (CT of the chest).
- Patients colonised with Pseudomonas Aeruginosa.
- Able to give informed consent.
Exclusion Criteria:
- Current smokers or ex-smokers of less than 1 year; >15 pack year history
- Cystic fibrosis
- Active allergic bronchopulmonary aspergillosis
- Active tuberculosis
- Poorly controlled asthma
- Pregnancy or breast feeding
- Known allergy to statins
- Active malignancy
- Chronic liver disease
- Established cardiovascular or cerebrovascular disease
- Statin use in the last year
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01299194
| United Kingdom | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, Scotland, United Kingdom, EH16 4SA | |
| Principal Investigator: | Adam T Hill, MBChB MD | NHS Lothian |
More Information
No publications provided
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01299194 History of Changes |
| Other Study ID Numbers: | 2010-022042-24 |
| Study First Received: | October 21, 2010 |
| Last Updated: | January 22, 2014 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Edinburgh:
|
BRONCHIECTASIS PSEUDOMONAS AERUGINOSA STATIN OUTCOME |
Additional relevant MeSH terms:
|
Bronchiectasis Bronchial Diseases Respiratory Tract Diseases Atorvastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015