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Completed

NCT Number: NCT00415350

Bronchiectasis and Long Term Azithromycin Treatment

1. SUMMARY

Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an improvement of symptoms. Also the number of exacerbations may lowered.

Objective: A reduction in number of infective exacerbations and improvement in lung function by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are: symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse events.

Study design: Randomised double blind multicenter study in the Netherlands. Patients will be stratified for colonisation with P.aeruginosa.

Study population: Patients with bronchiectasis demonstrated by high-resolution computed tomography (HR-CT) scan or bronchography.

Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.

Main study parameters/endpoints: Reduction in number exacerbations, defined as increase symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary endpoint.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of participating in this study is low. Laboratory, radiographic examinations, and pulmonary function tests are commonly used as diagnostic procedures during outpatients visits and during exacerbations. Adverse effects in maintenance treatment with AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function tests are observed. A better quality of life will probably be the beneficial effect of long term treatment with AZT. This will be achieved by a reduction in respiratory and non-respiratory symptoms and number of exacerbations.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkmaar Medical Center, Alkmaar, N-H, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18 ≥ years
  • Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
  • Minimal 3 lower respiratory tract infections (LRTI) treated with oral/intravenous (IV) antibiotics in the year preceding the study inclusion.
  • The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
  • At least one positive sputum culture in the preceding year.
  • Informed consent

Exclusion criteria

  • Previous ( ≥ 4 weeks) prolonged macrolide therapy.
  • Pregnant or lactating women.
  • Allergy to macrolides.
  • Intolerance to macrolides.
  • Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
  • Use of antibiotics within 14 days of screening.
  • Use of oral or IV corticosteroids (≥ 30 mg prednisolone/daily) within 30 days of screening.
  • Other research medication started 2 months prior to inclusion.

Treatment and study plan

Azithromycin

Drug

Azithromycin Tablet 250 mg daily

Placebo

Other

Placebo tablet 1 daily

Primary outcomes

  1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?

    Time frame: 1 year

  2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?

    Time frame: 1 year

Secondary outcomes

  1. Is there any improvement in symptom score during treatment with AZM?

    Time frame: 1 year

  2. What is the effect of AZM on bacterial colonisation?

    Time frame: 1 year

  3. Does treatment with AZM reduce inflammatory parameters?

    Time frame: 1 year

  4. Does treatment with AZM change the quality of life?

    Time frame: 1 year

  5. Is there any differences in adverse events between AZM and placebo treatment?

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

W.G.Boersma

Other

Registry information

Official study title

Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment

Acronym: BAT

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 22, 2006
Registry last updated
May 28, 2020

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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