Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa
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|ClinicalTrials.gov Identifier: NCT01299194|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : May 3, 2017
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 or disease||Intervention/treatment||Phase|
|BRONCHIECTASIS||Drug: ATORVASTATIN||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas Aeruginosa|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||May 2017|
Active Comparator: ATORVASTATIN
Atorvastatin 80mg once daily for 3 months, 1.5 month wash out, then Placebo for 3 months
80mg once daily for 3 months
Placebo Comparator: PLACEBO
Placebo 3 months, then washout for 1.5 months, then Atorvastatin 80mg once daily
80mg once daily for 3 months
- 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 ]
- pulmonary physiology and assessment of exercise capacity [ Time Frame: 7.5 months ]
- 24 hour sputum volume [ Time Frame: 7.5 months ]
- qualitative and quantitative bacteriology [ Time Frame: 7.5 months ]
- health related quality of life and health care utilisation [ Time Frame: 7.5 months ]
- exacerbation frequency [ Time Frame: 7.5 months ]
- safety of statin therapy [ Time Frame: 7.5 months ]
- Airways and systemic inflammation [ Time Frame: 7.5 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299194
|Royal Infirmary of Edinburgh|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|Principal Investigator:||Adam T Hill, MBChB MD||NHS Lothian|