Effect of Statins on Asthma Control in Smokers With Asthma | NCT00463827

Studies
Effect of Statins on Asthma Control in Smokers With Asthma

NCT00463827

Sponsor

NHS Greater Clyde and Glasgow

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

71Actual

Phase

Phase 2

Conditions

Asthma
COPD
Smoking

Interventions

Atorvastatin
atorvastatin
matched placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Apr 18, 2007

First Submission Date that Met QC Criteria

Apr 18, 2007

First Posted Date

Apr 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neil Thomson, Professor of Respiratory Medicine, NHS Greater Clyde and GlasgowPrincipal Investigator

Lead Sponsor

NHS Greater Clyde and GlasgowOTHER

Collaborators

Name	Class
University of Glasgow	OTHER
Medical Research Council	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Asthma is a chronic inflammatory condition of the lungs.

There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers.

Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties.

In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. The investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

Detailed Description

Despite several studies, which have shown that smokers with asthma have more severe symptoms, accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids, more than 25% of asthmatics continue to smoke. Smoking cessation advice is often ineffective.

Statins are used as cholesterol lowering agents, however, there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma.

This is a randomised placebo controlled double-blind parallel group study.

Following screening to assess suitability for the study, patients will be randomised to treatment with either Atorvastatin 40mg or placebo (blank tablet)for 8 weeks.

After 4 weeks of treatment, all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Atorvastatin 40	Drug: Atorvastatin
placebo	Placebo Comparator	matched placebo	Drug: matched placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug		2
atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in peak flow data		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
sputum cell counts		4 weeks and 8 weeks
spirometry		4 weeks and 8 weeks
airway responsiveness to methacholine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of asthma for more than 1 year
Symptomatic asthma
Smoker with greater than 5 pack year history
On short acting bronchodilator only- although may have medication weaned if stable

Exclusion Criteria:

Ex-smokers or non-smokers
Patients already on statin therapy
Unstable asthma
Previous statin sensitivity or myopathy or myositis
On any medications known to interact with statins

Note separate entry criteria for pilot study of COPD patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Thomson, FRCP	University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gartnavel General Hospital		Glasgow		G12 0YN	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21473764	Derived	Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive
D012907	Smoking

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds