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Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype

NCT07795086 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-31

No results posted yet for this study

Summary

"The study is a randomized controlled trial comparing roflumilast and azithromycin as add-on therapies in 70 patients with severe chronic obstructive pulmonary disease (COPD ) and frequent exacerbations. Participants will receive one of the two treatments for six months while continuing standard inhaled therapy. The study aims to determine which drug is more effective in reducing exacerbations and improving clinical outcomes such as forced expiratory volume in one second( FEV1) and modified medical research council ( mMRC)dyspnea scale , hospitalization, adherence, and safety, thereby providing evidence to guide chronic obstructive pulmonary disease management in our local population."

Conditions

  • Chronic Obstructive Pulmonary Disease With Exacerbation

Interventions

DRUG

Roflumilast Oral Tablet

out of total 70 patients , 35 patients will receive roflumilast 500 microgram once daily

DRUG

Azithromycin 250 mg

out of 70 patients 35 patients will receive azithromycin 250mg once daily

Sponsors & Collaborators

  • Sheikh Zayed Medical College

    collaborator OTHER_GOV

  • Sidra Aziz

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2027-02-28
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795086 on ClinicalTrials.gov