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

Outcome Study to Evaluate the Role of Klaricid XL (Clarithromycin Modified Release) in the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Its Impact on Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)

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.

Study Overview

• Status: Completed
• Conditions: Bronchitis
• Intervention / Treatment: Drug: Clarithromycin modified release 500 mg

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 Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Pakistan
  • Faisalabad, Pakistan
    • Site Ref # / Investigator 54026
  • Faisalabad, Pakistan
    • Site Ref # / Investigator 54028
  • Faisalabad, Pakistan
    • Site Ref # / Investigator 54029
  • Hyderabad, Pakistan
    • Site Ref # / Investigator 54015
  • Hyderabad, Pakistan
    • Site Ref # / Investigator 54016
  • Hyderabad, Pakistan
    • Site Ref # / Investigator 54017
  • Hyderabad, Pakistan
    • Site Ref # / Investigator 54018
  • Islamabad, Pakistan
    • Site Ref # / Investigator 54035
  • Karachi, 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
  • Lahore, Pakistan
    • Site Ref # / Investigator 54019
  • Lahore, Pakistan
    • Site Ref # / Investigator 54020
  • Lahore, Pakistan
    • Site Ref # / Investigator 54022
  • Lahore, Pakistan
    • Site Ref # / Investigator 54023
  • Multan, Pakistan
    • Site Ref # / Investigator 54040
  • Multan, Pakistan
    • Site Ref # / Investigator 54043
  • Multan, Pakistan
    • Site Ref # / Investigator 55270
  • Peshawar, Pakistan
    • Site Ref # / Investigator 55273
  • Rawalpindi, Pakistan
    • Site Ref # / Investigator 54033
  • KP
    • Peshawar, KP, Pakistan
      • Site Ref # / Investigator 54037
  • Punjab
    • Multan, Punjab, Pakistan, 60000
      • Site Ref # / Investigator 54044

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment	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.	Baseline, End of Treatment (maximum treatment duration of 10 days)
Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment	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).	Baseline, End of Treatment (maximum treatment duration of 10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	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.	From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Raeef Ahmed, MD, Abbott

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 1, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Bronchitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: P12-822