Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa

NCT01299194 | Completed Phase 4

• 1 other identifier: 2010-022042-24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

BRONCHIECTASIS

Keywords

BRONCHIECTASIS; PSEUDOMONAS AERUGINOSA; STATIN; OUTCOME

Outcome Measures

Primary Outcomes (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.

  7.5 months

Secondary Outcomes (7)

• pulmonary physiology and assessment of exercise capacity

  7.5 months

• 24 hour sputum volume

  7.5 months

• qualitative and quantitative bacteriology

  7.5 months

• health related quality of life and health care utilisation

  7.5 months

• exacerbation frequency

  7.5 months

Study Arms (2)

ATORVASTATIN

ACTIVE COMPARATOR

Atorvastatin 80mg once daily for 3 months, 1.5 month wash out, then Placebo for 3 months

Drug: ATORVASTATIN

PLACEBO

PLACEBO COMPARATOR

Placebo 3 months, then washout for 1.5 months, then Atorvastatin 80mg once daily

Drug: ATORVASTATIN

Interventions

ATORVASTATIN DRUG

80mg once daily for 3 months

ATORVASTATIN; PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

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)

• Bedi P, Chalmers JD, Graham C, Clarke A, Donaldson S, Doherty C, Govan JRW, Davidson DJ, Rossi AG, Hill AT. A Randomized Controlled Trial of Atorvastatin in Patients With Bronchiectasis Infected With Pseudomonas Aeruginosa: A Proof of Concept Study. Chest. 2017 Aug;152(2):368-378. doi: 10.1016/j.chest.2017.05.017. Epub 2017 May 26.

  PMID: 28554732 DERIVED

MeSH Terms

Conditions

Bronchiectasis; Pseudomonas Infections

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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: CROSSOVER
• 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: June 1, 2015
• Study Completion: May 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

GB (1)