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A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01299181
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : August 28, 2013
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
The investigators hypothesise that long term statin treatment will improve patients' symptoms through its anti-inflammatory effect. The beneficial effects on patient symptoms (cough, sputum volume, bacterial load, airway function, exercise tolerance, exacerbation frequency and health related quality of life) will be consequent on reduced neutrophilic airways inflammation.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel 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
Study Start Date : November 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Atorvastatin
Atorvastatin 80mg once daily
Drug: Atorvastatin
80mg once daily orally

Placebo Comparator: Placebo
Drug: Atorvastatin
80mg once daily orally

Primary Outcome Measures :
  1. The primary endpoint of this study is a reduction in cough at 6 months compared to baseline as measured by the Leicester Cough Questionnaire score. [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18-75 will be recruited. All will have an established radiological diagnosis of bronchiectasis (CT of the chest). Patients will have clinically significant bronchiectasis expectorating mucopurulent or purulent sputum when clinically stable with at least 2 chest infections per year.

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
  • patients on long term oral macrolides due to the interaction with statin therapy patients chronically colonised with Pseudomonas aeruginosa (defined as two or more isolates of Pseudomonas aeruginosa whilst clinically stable in 6 months prior to the study).

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 identifier (NCT number): NCT01299181

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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
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Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Edinburgh Identifier: NCT01299181    
Other Study ID Numbers: 2010-022040-20
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by University of Edinburgh:
Statin therapy
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors