Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis

NCT ID: NCT01354938

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-01-31

Brief Summary

The objective of this study was to evaluate the role of Klaricid XL (clarithromycin modified release) in the treatment of acute exacerbation of chronic bronchitis (AECB) and its impact on improving the quality of life.

Detailed Description

Participants in this observational study had a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation, clinically diagnosed by the sudden worsening of symptoms characterized by extreme breathlessness and increased chest tightness, wheezing, cough, or sputum changes. A sequential non-systematic sample of patients with AECB from May 2011 until January 04, 2012 is included in this observational study.

The observation period for each individual patient started with the diagnosis of the acute exacerbation of chronic bronchitis and prescription of antimicrobial medication per routine clinical care. This observational period continued during the treatment period and ended on at least one follow-up visit at the end of the treatment. Duration of treatment was based on physician's judgment of severity of the patient's condition. The usual treatment period ranges from 5 to 14 days.

Conditions

Bronchitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Exacerbation of Chronic Bronchitis (AECB)

Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day based on physician's decision of severity of symptoms per routine clinical care.

Clarithromycin modified release 500 mg

Intervention Type: DRUG

Clarithromycin modified release 500 mg was prescribed. The dosage given was either 1 tablet or 2 tablets once a day, depending on the severity of the treatment.

Interventions

Clarithromycin modified release 500 mg

Clarithromycin modified release 500 mg was prescribed. The dosage given was either 1 tablet or 2 tablets once a day, depending on the severity of the treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with acute exacerbation of chronic bronchitis who required antimicrobial therapy and treated with Klaricid XL (clarithromycin modified release)
• Male and female patients age 35 years and older

Exclusion Criteria

• Patients with clinical signs and symptoms suggesting pneumonia
• Patients with asthma
• Patients with any concomitant illness that may confound the interpretation of the effect of study medication (e.g., pulmonary malignancy, congestive heart failure, bronchiectasis, pneumothorax)
• Immunocompromised patients; however, patients receiving systemic steroids at baseline for the treatment of chronic obstructive pulmonary disease can be enrolled
• Pregnant females
• Nursing mothers
• Patients who are allergic to clarithromycin

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raeef Ahmed, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Ref # / Investigator 54037

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Ref # / Investigator 54044

Multan, Punjab Province, Pakistan

Site Ref # / Investigator 54026

Faisalabad, , Pakistan

Site Ref # / Investigator 54028

Faisalabad, , Pakistan

Site Ref # / Investigator 54029

Faisalabad, , Pakistan

Site Ref # / Investigator 54015

Hyderābād, , Pakistan

Site Ref # / Investigator 54016

Hyderābād, , Pakistan

Site Ref # / Investigator 54017

Hyderābād, , Pakistan

Site Ref # / Investigator 54018

Hyderābād, , Pakistan

Site Ref # / Investigator 54035

Islamabad, , Pakistan

Site Ref # / Investigator 54002

Karachi, , Pakistan

Site Ref # / Investigator 54003

Karachi, , Pakistan

Site Ref # / Investigator 54004

Karachi, , Pakistan

Site Ref # / Investigator 54005

Karachi, , Pakistan

Site Ref # / Investigator 54006

Karachi, , Pakistan

Site Ref # / Investigator 54007

Karachi, , Pakistan

Site Ref # / Investigator 54009

Karachi, , Pakistan

Site Ref # / Investigator 54010

Karachi, , Pakistan

Site Ref # / Investigator 54013

Karachi, , Pakistan

Site Ref # / Investigator 54019

Lahore, , Pakistan

Site Ref # / Investigator 54020

Lahore, , Pakistan

Site Ref # / Investigator 54022

Lahore, , Pakistan

Site Ref # / Investigator 54023

Lahore, , Pakistan

Site Ref # / Investigator 54040

Multan, , Pakistan

Site Ref # / Investigator 54043

Multan, , Pakistan

Site Ref # / Investigator 55270

Multan, , Pakistan

Site Ref # / Investigator 55273

Peshawar, , Pakistan

Site Ref # / Investigator 54033

Rawalpindi, , Pakistan

Countries

Pakistan

Other Identifiers

P12-822

Identifier Type: -

Identifier Source: org_study_id