AsthmaPhase 3NCT00852579
Effects of Macrolides on Asthma Control
A Phase 3 study testing Azithromycin in people with Asthma, run by Euan J Cameron at 2 sites in United Kingdom.
Trial summary
Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2009to Aug 2011
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma
- Age 18-70
- Current smoker
- Duration of symptoms >1yr with stability for 4 weeks
- Able to maintain asthma without exacerbations during run in period
- Able to wean off other asthma medication
Who cannot join
- Ex-smokers or never smokers
- Planning to quit smoking during duration of trial
- Patients with unstable asthma
- Patients with current epilepsy, psychosis or history of significant atrial or ventricular tachyarrhythmia
- Corrected QT-interval greater than 450msec in women, 430msec in men
- Low potassium levels. If can be corrected then screening can continue with confirmation of normal levels prior to taking study medication
Show all 18Show fewer
- Liver disease (ALT and/or AST levels 2 or more times ULN)
- Significant renal disease (Creatinine or urea levels 2 or more times ULN)
- Any previous severe adverse reactions to macrolides
- Patients who are known to have specific IgE sensitivity or skin test positivity to grass pollen and a history of worsening of asthma due to hay fever will not be recruited from mid May to the end of July
- Upper or lower respiratory tract infection in the 4 weeks prior to randomisation. Run in period can be prolonged in this situation to have 4 weeks with no respiratory infection prior to randomisation.
- Patients who require medications known to interact with azithromycin
- On other immunosuppressants or chronic antibiotics
- Weight less than 45kg
- Frequent asthma exacerbations (greater than 4) requiring oral corticosteroids in the year prior to randomisation
- Current or past diagnosis of allergic-bronchopulmonary-aspergillosis
- Pregnancy and breast feeding
- Mental impairment or language difficulties that makes informed consent not possible
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gartnavel General Hospital
Glasgow, G12 0YN
Crosshouse Hospital
Kilmarnock, KA2 0BE
About this study
Official title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.
- Conditions
- Asthma
- Being tested
- Azithromycin, Placebo
- Keywords
- Asthma, Smoker, Macrolide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Daily dose 250mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active treatment. Receives: Drug: Azithromycin |
| 2 | Placebo comparator | Placebo control group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow rate.
Measured: 12 weeks
Secondary outcomes (9)
Spirometry
Measured: 12 weeks
Asthma control score
Measured: 12 weeks
Average of last 7 days PEF measurements
Measured: 12 weeks
Sputum cell counts
Measured: 12 weeks
Fraction of expired nitric oxide
Measured: 12 weeks
Airway responsiveness to methacholine
Measured: 12 weeks
Exacerbation rates
Measured: 12 weeks
Cough score
Measured: 12 weeks
Diary symptom score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Euan J Cameron
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor-investigator, Euan J Cameron, University of Glasgow
- Investigators
- Neil C Thomson, FRCP, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852579
- Sponsor's protocol ID
- AR010
- Other IDs
- EUDRACT 2008-007240-34, MRC Grant G0701626, NRES 09/S0703/23
- Status last verified
- Oct 2011
- First submitted
- 26 Feb 2009
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomson NC, Chaudhuri R, Livingston E. Asthma and cigarette smoking. Eur Respir J. 2004 Nov;24(5):822-33. doi: 10.1183/09031936.04.00039004.
PubMed 15516679Richeldi L, Ferrara G, Fabbri LM, Lasserson TJ, Gibson PG. Macrolides for chronic asthma. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002997. doi: 10.1002/14651858.CD002997.pub3.
PubMed 16235309Cameron EJ, Chaudhuri R, Mair F, McSharry C, Greenlaw N, Weir CJ, Jolly L, Donnelly I, Gallacher K, Morrison D, Spears M, Evans TJ, Anderson K, Thomson NC. Randomised controlled trial of azithromycin in smokers with asthma. Eur Respir J. 2013 Nov;42(5):1412-5. doi: 10.1183/09031936.00093913. Epub 2013 Sep 13. No abstract available.
PubMed 24036246
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
- ClinicalTrials.gov ID
- NCT00852579
- Acronym / sponsor ID
- AR010
- Conditions
- Asthma
- Keywords
- Asthma, Smoker, Macrolide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Euan J CameronUniversity, hospital or other
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde
- Study start
- Mar 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Feb 2009 (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 common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AzithromycinActive treatment. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of asthma
- Age 18-70
- Current smoker
- Duration of symptoms >1yr with stability for 4 weeks
- Able to maintain asthma without exacerbations during run in period
Key exclusion criteria (18 listed)
- Ex-smokers or never smokers
- Planning to quit smoking during duration of trial
- Patients with unstable asthma
- Patients with current epilepsy, psychosis or history of significant atrial or ventricular tachyarrhythmia
- Corrected QT-interval greater than 450msec in women, 430msec in men
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 |
|---|---|---|
| AzithromycinDaily dose 250mg | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Peak expiratory flow rate.
Time frame: 12 weeks
9 secondary outcomes
Spirometry
Time frame: 12 weeks
Asthma control score
Time frame: 12 weeks
Average of last 7 days PEF measurements
Time frame: 12 weeks
Sputum cell counts
Time frame: 12 weeks
Fraction of expired nitric oxide
Time frame: 12 weeks
Airway responsiveness to methacholine
Time frame: 12 weeks
Exacerbation rates
Time frame: 12 weeks
Cough score
Time frame: 12 weeks
Diary symptom score
Time frame: 12 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 19 Oct 2011.
- Background: PubMed 15516679Thomson NC, Chaudhuri R, Livingston E. Asthma and cigarette smoking. Eur Respir J. 2004 Nov;24(5):822-33. doi: 10.1183/09031936.04.00039004.
- Background: PubMed 16235309Richeldi L, Ferrara G, Fabbri LM, Lasserson TJ, Gibson PG. Macrolides for chronic asthma. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002997. doi: 10.1002/14651858.CD002997.pub3.
- Derived from this study: PubMed 24036246Cameron EJ, Chaudhuri R, Mair F, McSharry C, Greenlaw N, Weir CJ, Jolly L, Donnelly I, Gallacher K, Morrison D, Spears M, Evans TJ, Anderson K, Thomson NC. Randomised controlled trial of azithromycin in smokers with asthma. Eur Respir J. 2013 Nov;42(5):1412-5. doi: 10.1183/09031936.00093913. Epub 2013 Sep 13. No abstract available.
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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 C Thomson, FRCP principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Asthma, run by Euan J Cameron at 2 sites 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 6 inclusion and 18 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 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Peak expiratory flow rate. (time frame: 12 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 NCT00852579, which also lists 3 linked publications.
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 19 Oct 2011.