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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122040
• Other study ID #: 54-282-14-3-2
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2011
• Est. completion date: September 30, 2011

Study information

• Verified date: October 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2011
• Est. primary completion date: September 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Quality of Life
• Respiratory Function Tests

Intervention

Drug:
• Roxithromycin 300 MG
Roxithromycin 300 mg oral per day
• Placebo
Placebo one table oral once dialy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SGRQ scores	SGRQ scores	for 12 weeks
Secondary	pulmonary function tests	FEV1	24 weeks
Secondary	sputum volumes	sputum volume per day	24 wekse