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| ID | Type | Description | Link |
|---|---|---|---|
| 10/60/27 | Other Grant/Funding Number | NIHR EME |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin (Zithromax) | Experimental | 500 mg of azithromycin (2×250mg capsules) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zithromax | Drug | 250mg * 2 capsules once daily for three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diary card summary symptom score | Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation. | 10 days after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by acute asthma QolQ (Juniper) |
| 5 & 10 days post randomisation |
| Time to 50% reduction in symptom score |
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Inclusion criteria
Patients meeting all of the following criteria will be considered for admission to the study:
Exclusion criteria
Patients presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian L Johnston, MBBS, PhD, FRCP | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnsley Hospital NHS Foundation | Barnsley | England | S75 2EP | United Kingdom | ||
| Countess of Chester Hospital NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27653939 | Derived | 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. |
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| Placebo | Drug | Lactose powder |
|
| 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% | 5 & 10 days post randomisation |
| Liverpool |
| England |
| CH2 1UL |
| United Kingdom |
| Surrey & Sussex Healthcare NHS Trust | Redhill | England | RH1 5RH | United Kingdom |
| Heart of England NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | FY3 8NR | United Kingdom |
| University of Glasgow | Glasgow | G12 0YN | United Kingdom |
| University Hospitals of Leicester NHS Foundation Trust | Leicester | LE39QP | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W2 1PG | United Kingdom |
| University Hospital of South Manchester Foundation Trust | Manchester | M23 9QZ | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | NE7 7DN | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
| University Hospital of North Tees | Stockton-on-Tees | TS19 8PE | United Kingdom |
| Sherwood Forest Hospitals NHS Foundation Trust | Sutton in Ashfield | NG17 4JL | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012120 | Respiration Disorders |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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