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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
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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Brief Summary:

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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : May 2017

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. pulmonary physiology and assessment of exercise capacity [ Time Frame: 7.5 months ]
  2. 24 hour sputum volume [ Time Frame: 7.5 months ]
  3. qualitative and quantitative bacteriology [ Time Frame: 7.5 months ]
  4. health related quality of life and health care utilisation [ Time Frame: 7.5 months ]
  5. exacerbation frequency [ Time Frame: 7.5 months ]
  6. safety of statin therapy [ Time Frame: 7.5 months ]
  7. Airways and systemic inflammation [ Time Frame: 7.5 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01299194     History of Changes
Other Study ID Numbers: 2010-022042-24
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by University of Edinburgh:
BRONCHIECTASIS
PSEUDOMONAS AERUGINOSA
STATIN
OUTCOME

Additional relevant MeSH terms:
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Bronchiectasis
Pseudomonas Infections
Bronchial Diseases
Respiratory Tract Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Atorvastatin
Anti-Inflammatory Agents
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors