NCT04122040

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 quality-of-life

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 quality-of-life

Status
completed

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

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2011

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 8, 2019

Last Update Submit

October 10, 2019

Conditions

Quality of LifeRespiratory Function Tests

Keywords

Bronchiectasisquality of lifepulmonary function tests

Outcome Measures

Primary Outcomes (1)

  • SGRQ scores

    SGRQ scores

    for 12 weeks

Secondary Outcomes (2)

  • pulmonary function tests

    24 weeks

  • sputum volumes

    24 wekse

Study Arms (2)

roxithromycin

ACTIVE COMPARATOR

roxithromycin 300 mg oral per day

Drug: Roxithromycin 300 MG

placebo

PLACEBO COMPARATOR

placebo one tablet per day

Drug: Placebo

Interventions

Roxithromycin 300 MGDRUG

Roxithromycin 300 mg oral per day

Also known as: Roxithromycin
roxithromycin
PlaceboDRUG

Placebo one table oral once dialy

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic bronchiectasis Stable clinical bronchiectasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nakamura H, Fujishima S, Inoue T, Ohkubo Y, Soejima K, Waki Y, Mori M, Urano T, Sakamaki F, Tasaka S, Ishizaka A, Kanazawa M, Yamaguchi K. Clinical and immunoregulatory effects of roxithromycin therapy for chronic respiratory tract infection. Eur Respir J. 1999 Jun;13(6):1371-9. doi: 10.1183/09031936.99.13613809.

    PMID: 10445614BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Interventions

Roxithromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Kanung Saejiam, MS

    Prince of Songkla University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
block of 4
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

March 1, 2011

Primary Completion

September 30, 2011

Study Completion

September 30, 2011

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share