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

Completed

• Conditions: Bronchitis
• Interventions: Drug: Clarithromycin modified release 500 mg

• Registration Number: NCT01354938
• Lead Sponsor: Abbott

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Results First Posted: 2013-01-30
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Exacerbation of Chronic Bronchitis (AECB)	Clarithromycin modified release 500 mg	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.

Primary Outcome Measures

Name	Time	Method
St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment	Baseline, End of Treatment (maximum treatment duration of 10 days)	The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the participant.
Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment	Baseline, End of Treatment (maximum treatment duration of 10 days)	The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. The change from Baseline of 4 or more units lower, consistent with a clinically significant change in the participant, was considered in this study to be the 'minimal clinically important difference' (MCID).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)	AE=any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. SAE=an event meeting any of the following criteria: results in death, hospitalization, prolongation of hospitalization, is life-threatening, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention, spontaneous or elective abortion. AEs and SAEs were collected during the course of the study. See the Reported Adverse Event section for details.

Trial Locations

Locations (28)

Site Ref # / Investigator 54037; 🇵🇰 Peshawar, KP, Pakistan

Site Ref # / Investigator 54026; 🇵🇰 Faisalabad, Pakistan

Site Ref # / Investigator 54029; 🇵🇰 Faisalabad, Pakistan

Site Ref # / Investigator 54035; 🇵🇰 Islamabad, Pakistan

Site Ref # / Investigator 54004; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54023; 🇵🇰 Lahore, Pakistan

Site Ref # / Investigator 54005; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54006; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54007; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54010; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54043; 🇵🇰 Multan, Pakistan

Site Ref # / Investigator 54033; 🇵🇰 Rawalpindi, Pakistan

Site Ref # / Investigator 54044; 🇵🇰 Multan, Punjab, Pakistan

Site Ref # / Investigator 54028; 🇵🇰 Faisalabad, Pakistan

Site Ref # / Investigator 54018; 🇵🇰 Hyderabad, Pakistan

Site Ref # / Investigator 54016; 🇵🇰 Hyderabad, Pakistan

Site Ref # / Investigator 54015; 🇵🇰 Hyderabad, Pakistan

Site Ref # / Investigator 54017; 🇵🇰 Hyderabad, Pakistan

Site Ref # / Investigator 54003; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54002; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54040; 🇵🇰 Multan, Pakistan

Site Ref # / Investigator 54013; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54009; 🇵🇰 Karachi, Pakistan

Site Ref # / Investigator 54019; 🇵🇰 Lahore, Pakistan

Site Ref # / Investigator 54020; 🇵🇰 Lahore, Pakistan

Site Ref # / Investigator 54022; 🇵🇰 Lahore, Pakistan

Site Ref # / Investigator 55270; 🇵🇰 Multan, Pakistan

Site Ref # / Investigator 55273; 🇵🇰 Peshawar, Pakistan