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

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ClinicalTrials.gov Identifier: NCT01299181
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
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

  Show Detailed Description

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
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01299181


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01299181     History of Changes
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:
Bronchiectasis
Outcome
Statin therapy

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