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Trial record 14 of 43 for:    "Bronchial Disease" | "Azithromycin"

AZISAST Study: AZIthromycin in Severe ASThma Study (AZISAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760838
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Azithromycin 250 mg Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Azithromycin

Azithromycin 250 mg

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

Drug: Azithromycin 250 mg
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 Comparator: placebo


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

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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. patients who have given written informed consent
  2. males or females of any race
  3. 18-75 years of age
  4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
  5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
  6. patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
  7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria:

  1. females who are pregnant or who are breastfeeding
  2. patients with severe bronchiectasis
  3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
  4. 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
  5. who are unable to perform spirometry or complete a patient diary or complete questionnaires
  6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics
  7. patients who's heart rate corrected QT interval is prolonged
  8. patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
  9. patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
  10. anti-IgE treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760838

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Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
ZNA Middelheim
Antwerpen, Belgium, 2020
AZ Sint-Jan Brugge
Brugge, Belgium, 8000
Ghent University Hospital
Ghent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
AZ Heilig Hart Roeselare
Roeselare, Belgium, 8800
Sponsors and Collaborators
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
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Principal Investigator: Guy Brusselle, MD, PhD University Hospital, Ghent

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Ghent Identifier: NCT00760838     History of Changes
Other Study ID Numbers: 2008/445
IWT 070709
First Posted: September 26, 2008    Key Record Dates
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by University Hospital, Ghent:
Inadequately controlled severe asthma

Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents