AZISAST Study: AZIthromycin in Severe ASThma Study

NCT00760838 | Completed Phase 4 Results

• 2 other identifiers: 2008/445IWT 070709
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Asthma

Keywords

Inadequately controlled severe asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  from baseline to week 26

Secondary Outcomes (5)

• Proportion of Participants Using Rescue Medication From Baseline to Week 26

  from baseline to week 26

• Peakflow Measurements

  from baseline to week 26

• Change in Forced Expiratory Volume in 1 Second

  from baseline to week 26

• Change in Total Score on Asthma Control Questionnaire (ACQ)

  from baseline to week 26

• Change in Total Score on the Asthma-related Quality of Life (AQLQ)

  from baseline to week 26

Study Arms (2)

Azithromycin

EXPERIMENTAL

Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards

Drug: Azithromycin 250 mg

placebo

PLACEBO COMPARATOR

Placebo 1x/day during 5 days 3x/week afterwards

Drug: Placebo

Interventions

Azithromycin 250 mg DRUG

Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

Azithromycin

Placebo DRUG

Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who have given written informed consent
• males or females of any race
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (7)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

AZ Heilig Hart Roeselare

Roeselare, 8800, Belgium

Location

Related Publications (2)

• 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.

  PMID: 34807989 DERIVED

• Brusselle 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.

  PMID: 23291349 DERIVED

Related Links

• Website of the Ghent University Hospital

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: dr. Brusselle Guy
• Organization: Ghent University Hospital

guy.brusselle@uzgent.be

003293322604

Study Officials

• Guy Brusselle, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: March 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-06

Locations

BE (7)