AsthmaPhase 4AZISASTNCT00760838
AZISAST Study: AZIthromycin in Severe ASThma Study
A Phase 4 study testing Azithromycin 250 mg in people with Asthma, run by University Hospital, Ghent at 7 sites in Belgium.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Azithromycin 250 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 7 sitesBelgium
- Study dates
- Mar 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have given written informed consent
- males or females of any race
- 18-75 years of age
- with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
- receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
- patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
- patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.
Who cannot join
- females who are pregnant or who are breastfeeding
- patients with severe bronchiectasis
- patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
- patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
- who are unable to perform spirometry or complete a patient diary or complete questionnaires
- patients with known hypersensitivity to azithromycin or other macrolide antibiotics
Show all 10Show fewer
- patients who's heart rate corrected QT interval is prolonged
- patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
- patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
- anti-IgE treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, 9300
ZNA Middelheim
Antwerp, 2020
AZ Sint-Jan Brugge
Bruges, 8000
Ghent University Hospital
Ghent, 9000
AZ Groeninge
Kortrijk, 8500
Universitair Ziekenhuis Leuven
Leuven, 3000
AZ Heilig Hart Roeselare
Roeselare, 8800
About this study
Official title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.
- Conditions
- Asthma
- Being tested
- Azithromycin 250 mg, Placebo
- Keywords
- Inadequately controlled severe asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 250 mgDrug
Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
PlaceboDrug
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards Receives: Drug: Azithromycin 250 mg |
| placebo | Placebo comparator | Placebo
1x/day during 5 days 3x/week afterwards Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Severe Asthma Exacerbations
Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.
Measured: from baseline to week 26
Secondary outcomes (5)
Proportion of Participants Using Rescue Medication From Baseline to Week 26
proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.
This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26.
Measured: from baseline to week 26
Peakflow Measurements
change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second
Measured: from baseline to week 26
Change in Forced Expiratory Volume in 1 Second
Measured: from baseline to week 26
Change in Total Score on Asthma Control Questionnaire (ACQ)
A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.
ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff
Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)
Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: from baseline to week 26
Change in Total Score on the Asthma-related Quality of Life (AQLQ)
A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease
32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)
7-point Likert scale (7 = not impaired at all - 1 = severely impaired).
Scores range 1-7, with higher scores indicating better quality of life.
Measured: from baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Sponsor
- Investigators
- Guy Brusselle, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760838
- Sponsor's protocol ID
- 2008/445
- Other IDs
- IWT 070709
- Acronym
- AZISAST
- Status last verified
- Jun 2014
- First submitted
- 25 Sep 2008
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Undela K, Goldsmith L, Kew KM, Ferrara G. Macrolides versus placebo for chronic asthma. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD002997. doi: 10.1002/14651858.CD002997.pub5.
PubMed 34807989Brusselle GG, Vanderstichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, Verleden G, Demedts IK, Verhamme K, Delporte A, Demeyere B, Claeys G, Boelens J, Padalko E, Verschakelen J, Van Maele G, Deschepper E, Joos GF. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013 Apr;68(4):322-9. doi: 10.1136/thoraxjnl-2012-202698. Epub 2013 Jan 3.
PubMed 23291349
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
- ClinicalTrials.gov ID
- NCT00760838
- Acronym / sponsor ID
- AZISAST / 2008/445
- Conditions
- Asthma
- Keywords
- Inadequately controlled severe asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Azithromycin 250 mgAzithromycin 250 mg 1x/day during 5 days 3x/week afterwards |
| placebo | Placebo comparator | Drug: PlaceboPlacebo 1x/day during 5 days 3x/week afterwards |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients who have given written informed consent
- males or females of any race
- 18-75 years of age
- with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
- receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
Key exclusion criteria (10 listed)
- females who are pregnant or who are breastfeeding
- patients with severe bronchiectasis
- patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
- patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
- who are unable to perform spirometry or complete a patient diary or complete questionnaires
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 |
|---|---|---|
| Azithromycin 250 mgAzithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks | Drug | Azithromycin |
| PlaceboPlacebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks | Drug | placebo |
Primary outcome
Proportion of Participants With Severe Asthma Exacerbations
Time frame: from baseline to week 26
Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.
5 secondary outcomes
Proportion of Participants Using Rescue Medication From Baseline to Week 26
Time frame: from baseline to week 26
Peakflow Measurements
Time frame: from baseline to week 26
Change in Forced Expiratory Volume in 1 Second
Time frame: from baseline to week 26
Change in Total Score on Asthma Control Questionnaire (ACQ)
Time frame: from baseline to week 26
Change in Total Score on the Asthma-related Quality of Life (AQLQ)
Time frame: from baseline to week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34807989Undela K, Goldsmith L, Kew KM, Ferrara G. Macrolides versus placebo for chronic asthma. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD002997. doi: 10.1002/14651858.CD002997.pub5.
- Derived from this study: PubMed 23291349Brusselle GG, Vanderstichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, Verleden G, Demedts IK, Verhamme K, Delporte A, Demeyere B, Claeys G, Boelens J, Padalko E, Verschakelen J, Van Maele G, Deschepper E, Joos GF. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013 Apr;68(4):322-9. doi: 10.1136/thoraxjnl-2012-202698. Epub 2013 Jan 3.
- Website of the Ghent University HospitalLink provided by the sponsor.
Related trials for Asthma
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
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.
Guy Brusselle, MD, PhD principal investigator
University Hospital, Ghent
7 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 Azithromycin 250 mg in people with Asthma, run by University Hospital, Ghent at 7 sites in Belgium.
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 10 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With Severe Asthma Exacerbations (time frame: from baseline to week 26). 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 NCT00760838, which also lists 2 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 26 Jun 2014; AzTrials last refreshed its copy on 28 Oct 2026.