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

NCT01299181 | Completed Phase 4

• 1 other identifier: 2010-022040-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Outcome; Statin therapy

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (7)

• pulmonary physiology and assessment of exercise capacity

  6 months

• 24 hour sputum volume

  6 months

• qualitative and quantitative bacteriology

  6 months

• health related quality of life and health care utilisation

  6 months

• exacerbation frequency

  6 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 80mg once daily

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

80mg once daily orally

Atorvastatin; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Mandal P, Chalmers JD, Graham C, Harley C, Sidhu MK, Doherty C, Govan JW, Sethi T, Davidson DJ, Rossi AG, Hill AT. Atorvastatin as a stable treatment in bronchiectasis: a randomised controlled trial. Lancet Respir Med. 2014 Jun;2(6):455-63. doi: 10.1016/S2213-2600(14)70050-5. Epub 2014 Mar 24.

  PMID: 24717640 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Adam T Hill, MBChB MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: February 18, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

GB (1)