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

NCT ID: NCT04122040

Last Updated: 2019-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-01

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Quality of Life Respiratory Function Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised control study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
block of 4

Study Groups

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roxithromycin

roxithromycin 300 mg oral per day

Group Type ACTIVE_COMPARATOR

Roxithromycin 300 MG

Intervention Type DRUG

Roxithromycin 300 mg oral per day

placebo

placebo one tablet per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo one table oral once dialy

Interventions

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Roxithromycin 300 MG

Roxithromycin 300 mg oral per day

Intervention Type DRUG

Placebo

Placebo one table oral once dialy

Intervention Type DRUG

Other Intervention Names

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Roxithromycin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Siwasak Juthong

Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kanung Saejiam, MS

Role: STUDY_DIRECTOR

Prince of Songkla University

References

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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.

Reference Type BACKGROUND
PMID: 10445614 (View on PubMed)

Other Identifiers

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54-282-14-3-2

Identifier Type: -

Identifier Source: org_study_id

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