NCT04215172

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

December 18, 2019

Last Update Submit

July 20, 2020

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (2)

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

    1)-ototoxicity by whispered- voice test before starting treatment and monthly The examiner stands arm's length (0.6 m) behind the seated patient and whispers a combination of numbers and letters (for example, 4-K-2) and then asks the patient to repeat the sequence. If the patient responds correctly, hearing is considered normal; if the patient responds incorrectly, the test is repeated using a different number/letter combination The examiner always stands behind the patient to prevent lip reading The other ear is assessed similarly with a different combination of numbers and letters -2)-assessment of hepatotoxicity by measuring liver enzymes (aspartate transaminase AST, Alanine transaminase ALT (Unit/Liter)) before starting treatment and monthly. 3)-assessment of possible prolongation of QT interval (millimeters) by ECG (electrocardiogram) before starting treatment and monthly.

    two years

  • evaluate macrolides in treating COPD-bronchiectasis overlap syndrome regarding improvement of symptoms, frequency of exacerbations, systemic inflammatory response and pulmonary function tests.

    * symptoms: 1. Dyspnea score by mMRC (modified medical research council) score, with strenuous exercise 0 when hurrying or walking up a slight hill +1 Walks slower than people of the same age because of dyspnea +2 Stops for breath after walking 100 yards +3 Too dyspneic to leave house +4 2. sputum volume by (milliliter), 3. bronchiectasis health questionnaire (BHS) * exacerbation: Frequency of outpatient visits per month and hospital admission if happened (number\\month). * systemic inflammation: 1. CBC (complete blood count) (White Blood Cells(n/ microliter), differential count (%) 2. Erythrocyte Sedimentation Rate (millimeter/hour) 3. C-Reactive Protein (milligram\\ liter) * Microbiological: Change in microbiological picture based on sputum culture and sensitivity \- Functional: Change in FEV1 (forced expiratory volume at one second) (liter/second.) all these will be done before starting treatment and monthly.

    two years

Study Arms (2)

macrolides group

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.

Drug: Macrolides

conventional group

Every patient of this group will receive the conventional treatment.

Interventions

MacrolidesDRUG

administration of azithromycin three times weekly for six months

macrolides group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who are admittted toChest department of Assiut University Hospitals or visit its outpatients' clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Hurst JR, Elborn JS, De Soyza A; BRONCH-UK Consortium. COPD-bronchiectasis overlap syndrome. Eur Respir J. 2015 Feb;45(2):310-3. doi: 10.1183/09031936.00170014. No abstract available.

    PMID: 25653262BACKGROUND

  • Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.

    PMID: 20627931BACKGROUND

  • Martinez-Garcia MA, Miravitlles M. Bronchiectasis in COPD patients: more than a comorbidity? Int J Chron Obstruct Pulmon Dis. 2017 May 11;12:1401-1411. doi: 10.2147/COPD.S132961. eCollection 2017.

    PMID: 28546748BACKGROUND

  • Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

    PMID: 28128970BACKGROUND

  • Ni Y, Shi G, Yu Y, Hao J, Chen T, Song H. Clinical characteristics of patients with chronic obstructive pulmonary disease with comorbid bronchiectasis: a systemic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015 Jul 28;10:1465-75. doi: 10.2147/COPD.S83910. eCollection 2015.

    PMID: 26251586BACKGROUND

  • Figueiredo Bde C, Ibiapina Cda C. The role of macrolides in noncystic fibrosis bronchiectasis. Pulm Med. 2011;2011:751982. doi: 10.1155/2011/751982. Epub 2011 Sep 5.

    PMID: 22292118BACKGROUND

  • Chalmers JD. Bronchiectasis and COPD Overlap: A Case of Mistaken Identity? Chest. 2017 Jun;151(6):1204-1206. doi: 10.1016/j.chest.2016.12.027. No abstract available.

    PMID: 28599926BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Interventions

Macrolides

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

alaa s ali, assistant lacturer

CONTACT

01064336300a_s_a.1990@yahoo.com

maiada k hashem, lecturer

CONTACT

01006559662maiada.hashem@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 2, 2020

Study Start

August 1, 2020

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

July 22, 2020

Record last verified: 2020-07