Macrolides in COPD- Bronchiectasis Overlap

Brief Title

Macrolides in COPD- Bronchiectasis Overlap

Official Title

Safety and Efficacy of Long-Term Macrolide Therapy in Patients With COPD-Bronchiectasis Overlap Syndrome

Brief Summary

      To assess safety of long-term macrolide therapy in patients with COPD-bronchiectasis overlap
      syndrome And evaluate its efficacy in treating COPD-bronchiectasis overlap syndrome regarding
      change in clinical, functional and microbiological profile.

      To define the, clinical, radiological, functional and microbiological patterns of patients
      with COPD-bronchiectasis overlap syndrome
    

Detailed Description

      COPD and bronchiectasis share common symptoms of cough with sputum production and
      susceptibility to recurrent exacerbations driven by new or persistent infection The overlap
      between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area
      of research, and it is not covered by guidelines for clinical practice COPD is diagnosed on
      the basis of poorly reversible airflow obstruction and is therefore a physiological
      diagnosis. It is defined when an objective measure of airflow obstruction is associated with
      an abnormal inflammatory response of the lung to noxious stimuli, with cigarette smoke being
      the most common exposure in the developed world. Operationally, this implies that patients
      with any sufficient exposure and fixed airflow obstruction are labelled as having COPD.

      Bronchiectasis is diagnosed in the presence of airway dilatation and airway wall thickening
      on imaging (usually computed tomography (CT)), and is therefore a structural diagnosis.
      Clinically significant disease is present when imaging abnormalities are associated with
      symptoms of persistent or recurrent bronchial infection.

      in the 2014 Global initiative for chronic Obstructive Lung Disease guidelines, bronchiectasis
      was for the first time defined as a comorbidity of chronic obstructive pulmonary disease
      (COPD), and this change has been retained in the 2015 update, which emphasizes the influence
      of bronchiectasis in the natural history of COPD.

      The prevalence of bronchiectasis in patients with COPD is high, especially in advanced
      stages. The identification of bronchiectasis in COPD has been defined as a different clinical
      COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection
      and exacerbations, and poor prognosis.

      A recent meta-analysis by Du et al, of 5,329 COPD patients found a greatly increased
      exacerbation risk due to comorbid COPD with bronchiectasis compared to COPD alone.18
      Moreover, the risk of exacerbations rose almost two times higher, colonization of the lungs
      four times higher, severe airway obstruction 30 percent higher, and mortality two times
      higher. It is not surprising that such elevated risks are also associated with higher
      healthcare costs.

      Treatments useful in COPD may not be widely effective in bronchiectasis and vice versa.
      Inhaled corticosteroids provide perhaps the best example of this: they are widely used in
      COPD but not recommended for most patients with bronchiectasis . The reasons for this are
      unclear but probably reflect, in part, the diverse aetiology underlying bronchiectasis. In
      contrast, inhaled antibiotics, including antipseudomonal agents in appropriate patients, are
      of benefit and appear in current bronchiectasis guidelines ,but are not used routinely in
      stable COPD Macrolides, in addition to their antimicrobial effects, have decreased neutrophil
      chemotaxis and infiltration into the respiratory epithelium, inhibition of transcription
      factors leading to decreased proinflammatory cytokine production, down-regulation of adhesion
      molecule expression, inhibition of microbial virulence factors including biofilm formation,
      reduced generation of oxygen-free radicals, enhanced neutrophil apoptosis, and decreased
      mucus hypersecretion with improved mucociliary clearance.
    

Study Type

Observational

Primary Outcome

long-term macrolides therapy in patients with COPD-bronchiectasis overlap syndrome regarding ototoxicity, hepatotoxicity and cardiac toxicity

Condition

Bronchiectasis

Intervention

Macrolides

Study Arms / Comparison Groups

 macrolides group

Description:  Every patient of this group will be educated and instructed about usage, dosing and side effects of the drug.
Dose: azithromycin 500 mg three times weekly for 6 months. added to the conventional treatment.

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

60

Start Date

August 1, 2020

Completion Date

July 1, 2022

Primary Completion Date

January 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 18 years or above, male or female.

          -  Non / Ex-smokers.

          -  Confirmed diagnosis of bronchiectasis based on high-resolution computed tomography
             scan.

          -  Confirmed diagnosis of COPD based on pulmonary function test.

        Exclusion Criteria:

          -  Active smokers.

          -  Moderate to severe liver impairment (Child-Pugh B or C) and/or sever renal impairment
             (c. clearance less than 30ml/min).

          -  Patients who are known to be hypersensitive to macrolide.

          -  Patient with known or susceptible to have rhythm problems
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 01064336300, [email protected]

NCT ID

NCT04215172

Organization ID

COPD_bronchiactasis

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

, , 

Verification Date

July 2020