AsthmaPhase 2NCT00463827
Effect of Statins on Asthma Control in Smokers With Asthma
A Phase 2 study testing Atorvastatin in people with Asthma and COPD, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
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.
Read the 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.
- Being tested
- Atorvastatin, matched placebo
- Keywords
- asthma, smokers, statin, atorvastatin, randomised, placebo, cigarette, blind, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
atorvastatinDrug
atorvastatin 40mg
matched placeboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Atorvastatin 40 Receives: Drug: Atorvastatin |
| placebo | Placebo comparator | matched placebo Receives: Drug: matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak flow data
Measured: 4 weeks
Secondary outcomes (10)
sputum cell counts
Measured: 4 weeks and 8 weeks
spirometry
Measured: 4 weeks and 8 weeks
airway responsiveness to methacholine
Measured: 4 weeks and 8 weeks
symptom scores
Measured: 4 weeks and 8 weeks
Exhaled and alveolar NO
Measured: 4 weeks and 8 weeks
Exacerbation rates
Measured: 4 and 8 weeks
immunological tests in blood
Measured: 4 and 8 weeks
ACQ score
Measured: 4 and 8 weeks
AQLQ score
Measured: 4 and 8 weeks
Safety issues
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Clyde and Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Medical Research Council
- Responsible party
- Principal investigator, Neil Thomson, NHS Greater Clyde and Glasgow
- Investigators
- Neil Thomson, FRCP, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463827
- Sponsor's protocol ID
- AR 003
- Status last verified
- Mar 2017
- First submitted
- 18 Apr 2007
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21473764
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
- ClinicalTrials.gov ID
- NCT00463827
- Acronym / sponsor ID
- AR 003
- Keywords
- asthma, smokers, statin, atorvastatin, randomised, placebo, cigarette, blind
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- NHS Greater Clyde and GlasgowUniversity, hospital or other
- Collaborators
- University of Glasgow, Medical Research Council
- Study start
- Aug 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: AtorvastatinAtorvastatin 40 |
| placebo | Placebo comparator | Drug: matched placebomatched placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | 2 |
| atorvastatinatorvastatin 40mg | Drug | 2 |
| matched placeboMatched placebo | Drug | placebo |
Primary outcome
Change in peak flow data
Time frame: 4 weeks
10 secondary outcomes
sputum cell counts
Time frame: 4 weeks and 8 weeks
spirometry
Time frame: 4 weeks and 8 weeks
airway responsiveness to methacholine
Time frame: 4 weeks and 8 weeks
symptom scores
Time frame: 4 weeks and 8 weeks
Exhaled and alveolar NO
Time frame: 4 weeks and 8 weeks
Exacerbation rates
Time frame: 4 and 8 weeks
immunological tests in blood
Time frame: 4 and 8 weeks
ACQ score
Time frame: 4 and 8 weeks
AQLQ score
Time frame: 4 and 8 weeks
Safety issues
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Derived from this study: PubMed 21473764Braganza 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.
- Unit websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Thomson, FRCP principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Asthma and COPD, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak flow data (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.