Bronchiectasis and Long Term Azithromycin Treatment

Brief Title

Bronchiectasis and Long Term Azithromycin Treatment

Official Title

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

Brief Summary

      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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Bronchiectasis

Intervention

Azithromycin

Study Arms / Comparison Groups

 Azithromycin treatment 1

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

72

Start Date

April 2008

Completion Date

December 2010

Primary Completion Date

December 2009

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

W.G. Boersma, MD,PHD, , 

Location Countries

Netherlands

Location Countries

Netherlands

NCT ID

NCT00415350

Organization ID

BAT-2006-MCA1

Secondary IDs

BAT-2006

Responsible Party

Sponsor-Investigator

Study Sponsor

W.G.Boersma

Study Sponsor

W.G. Boersma, MD,PHD, Study Director, Medical Center Alkmaar, dep. Pulmomary Diseases

Verification Date

May 2020