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Completed

NCT Number: NCT00760838

AZISAST Study: AZIthromycin in Severe ASThma Study

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of Participants Using Rescue Medication From Baseline to Week 26

    Time frame: 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.

  2. Peakflow Measurements

    Time frame: from baseline to week 26

    change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second

  3. Change in Forced Expiratory Volume in 1 Second

    Time frame: from baseline to week 26

  4. Change in Total Score on Asthma Control Questionnaire (ACQ)

    Time frame: from baseline to week 26

    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).

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

    Time frame: from baseline to week 26

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study 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

Acronym: AZISAST

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2008
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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