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OpenTrials
Completed

NCT Number: NCT04122040

Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis

roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis

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Key information

Conditions

Quality of Life Bronchial Diseases Bronchiectasis Respiratory Function Tests Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

Who can participate

Healthy volunteers accepted: No

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

minimum 15 year maximum 75 years

Criteria inclusion Criteria:

Symptomatic bronchiectasis Stable clinical bronchiectasis

Exclusion criteria

Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating

Treatment and study plan

Roxithromycin 300 MG

Drug

Roxithromycin 300 mg oral per day

Other names: Roxithromycin

Placebo

Drug

Placebo one table oral once dialy

Primary outcomes

  1. SGRQ scores

    Time frame: for 12 weeks

    SGRQ scores

Secondary outcomes

  1. pulmonary function tests

    Time frame: 24 weeks

    FEV1

  2. sputum volumes

    Time frame: 24 wekse

    sputum volume per day

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2019
Registry last updated
Oct 14, 2019

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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