AsthmaPhase 4AZALEANCT01444469
AZithromycin Against pLacebo in Exacerbations of Asthma
A Phase 4 study testing Zithromax in people with Asthma, run by Imperial College London at 14 sites in United Kingdom.
Trial summary
Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Zithromax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- Sep 2011to Jun 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all of the following criteria will be considered for admission to the study:
- Adults, either sex, ages 18-55 years or age 56 to 65 with < 20 pack year smoking history or >65 with <5 pack year smoking history
- Patients with a documented history of asthma for >6 consecutive months, and
- Patients presenting within 48 hours (of initial presentation to medical care) with an acute deterioration in asthma control (increased wheeze, dyspnea and/or cough and/or reduced PEF) and requiring a course of oral steroids
- Patients with a PEF or FEV1 less than 80% of predicted normal or patient's best at presentation, at recruitment or in the time elapsed between presentation and recruitment
- Patients must be able to complete diaries and quality of life questionnaires.
- Patients must sign and date an informed consent prior to any study procedures.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure, patients on drugs known to prolong the QT interval and patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents.
- Smokers aged 56-65 with a >20 pack year history, or aged >65 with >5 pack year history
- Patients requiring immediate placement in ICU
- Patients who used oral or systemic antibiotics within 28 days prior to enrolment
- Patients with known impaired hepatic function (ALT/AST > 2 ULN)
Show all 17Show fewer
- Patients with significant lung disease (including COPD) other than asthma
- Patients with > 20mg oral corticosteroid maintenance therapy
- Patients requiring other antibiotic therapy
- Patients who are receiving other medications or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety
- Women who are breast-feeding or are pregnant, as demonstrated by a urine pregnancy test carried out before exposure to study medication or the start of any study procedure that could pose a risk to the foetus
- Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to Azithromycin or any of the macrolide or ketolide class of antibiotics, erythromycin or to any excipients thereof
- Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase
- Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making implementation of the protocol or interpretation of the study results difficult
- Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study.
- Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits.
- No subject will be allowed to enrol in this study more than once.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Barnsley Hospital NHS Foundation
Barnsley, England, S75 2EP
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR
University of Glasgow
Glasgow, G12 0YN
University Hospitals of Leicester NHS Foundation Trust
Leicester, LE39QP
Countess of Chester Hospital NHS Foundation Trust
Liverpool, England, CH2 1UL
Imperial College Healthcare NHS Trust
London, W2 1PG
University Hospital of South Manchester Foundation Trust
Manchester, M23 9QZ
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
Surrey & Sussex Healthcare NHS Trust
Redhill, England, RH1 5RH
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, NG17 4JL
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.
- Conditions
- Asthma
- Being tested
- Zithromax, Placebo
- Keywords
- Asthma exacerbations, Respiratory disease, Viral infection, Macrolide/ketolide antibiotics, Mycoplasma pneumoniae (M. pneumoniae), Chlamydophila pneumoniae (C. pneumoniae)
- Medical subject headings
- Asthma, Respiration Disorders, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZithromaxDrug
Also called Azithromycin
250mg * 2 capsules once daily for three days
PlaceboDrug
Lactose powder
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin (Zithromax) | Experimental | 500 mg of azithromycin (2×250mg capsules) Receives: Drug: Zithromax |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary card summary symptom score
Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.
Measured: 10 days after randomisation
Secondary outcomes (3)
Quality of life assessed by acute asthma QolQ (Juniper)
- Health status assessed by acute asthma QolQ (Juniper)
- Health status assessed by Mini Asthma QolQ (Juniper)
Measured: 5 & 10 days post randomisation
Time to 50% reduction in symptom score
Measured: From Visit 1 (day 1) to Visit 4 (day 42)
Pulmonary Function tests
Pulmonary function tests include: FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75% and FEF50%
Measured: 5 & 10 days post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJun 2014
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sebastian L Johnston, MBBS, PhD, FRCP, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444469
- Sponsor's protocol ID
- 2011-001093-26
- Other IDs
- 10/60/27
- Acronym
- AZALEA
- Status last verified
- Jan 2024
- First submitted
- 22 Sep 2011
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnston SL, Szigeti M, Cross M, Brightling C, Chaudhuri R, Harrison T, Mansur A, Robison L, Sattar Z, Jackson D, Mallia P, Wong E, Corrigan C, Higgins B, Ind P, Singh D, Thomson NC, Ashby D, Chauhan A; AZALEA Trial Team. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1630-1637. doi: 10.1001/jamainternmed.2016.5664.
PubMed 27653939
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
- ClinicalTrials.gov ID
- NCT01444469
- Acronym / sponsor ID
- AZALEA / 2011-001093-26
- Conditions
- Asthma
- Keywords
- Asthma exacerbations, Respiratory disease, Viral infection, Macrolide/ketolide antibiotics, Mycoplasma pneumoniae (M. pneumoniae), Chlamydophila pneumoniae (C. pneumoniae)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Sep 2011 (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.
Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.
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 |
|---|---|---|
| Azithromycin (Zithromax) | Experimental | Drug: Zithromax500 mg of azithromycin (2×250mg capsules) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients meeting all of the following criteria will be considered for admission to the study:
- Adults, either sex, ages 18-55 years or age 56 to 65 with < 20 pack year smoking history or >65 with <5 pack year smoking history
- Patients with a documented history of asthma for >6 consecutive months, and
- Patients presenting within 48 hours (of initial presentation to medical care) with an acute deterioration in asthma control (increased wheeze, dyspnea and/or cough and/or reduced PEF) and requiring a course of oral steroids
- Patients with a PEF or FEV1 less than 80% of predicted normal or patient's best at presentation, at recruitment or in the time elapsed between presentation and recruitment
Key exclusion criteria (17 listed)
- Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure, patients on drugs known to prolong the QT interval and patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents.
- Smokers aged 56-65 with a >20 pack year history, or aged >65 with >5 pack year history
- Patients requiring immediate placement in ICU
- Patients who used oral or systemic antibiotics within 28 days prior to enrolment
- Patients with known impaired hepatic function (ALT/AST > 2 ULN)
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 |
|---|---|---|
| ZithromaxAlso: Azithromycin250mg * 2 capsules once daily for three days | Drug | Azithromycin (Zithromax) |
| PlaceboLactose powder | Drug | Placebo |
Primary outcome
Diary card summary symptom score
Time frame: 10 days after randomisation
Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.
3 secondary outcomes
Quality of life assessed by acute asthma QolQ (Juniper)
Time frame: 5 & 10 days post randomisation
Time to 50% reduction in symptom score
Time frame: From Visit 1 (day 1) to Visit 4 (day 42)
Pulmonary Function tests
Time frame: 5 & 10 days post randomisation
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 10 Jan 2024.
- Derived from this study: PubMed 27653939Johnston SL, Szigeti M, Cross M, Brightling C, Chaudhuri R, Harrison T, Mansur A, Robison L, Sattar Z, Jackson D, Mallia P, Wong E, Corrigan C, Higgins B, Ind P, Singh D, Thomson NC, Ashby D, Chauhan A; AZALEA Trial Team. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1630-1637. doi: 10.1001/jamainternmed.2016.5664.
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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.
Sebastian L Johnston, MBBS, PhD, FRCP study chair
Imperial College London
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zithromax in people with Asthma, run by Imperial College London at 14 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 7 inclusion and 17 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Diary card summary symptom score (time frame: 10 days after randomisation). 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 NCT01444469, 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 10 Jan 2024.