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

October 10, 2019 updated by: Siwasak Juthong, Prince of Songkla University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: roxithromycin
roxithromycin 300 mg oral per day
Drug: Roxithromycin 300 MG
Roxithromycin 300 mg oral per day
Other Names:
  • Roxithromycin
PLACEBO_COMPARATOR: placebo
placebo one tablet per day
Drug: Placebo
Placebo one table oral once dialy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SGRQ scores
Time Frame: for 12 weeks
SGRQ scores
for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary function tests
Time Frame: 24 weeks
FEV1
24 weeks
sputum volumes
Time Frame: 24 wekse
sputum volume per day
24 wekse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2011

Primary Completion (ACTUAL)

September 30, 2011

Study Completion (ACTUAL)

September 30, 2011

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54-282-14-3-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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