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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Bronchitis	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 Design

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Study Type :	Observational
Actual Enrollment :	220 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	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)
Study Start Date :	May 2011
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment [ Time Frame: 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.
2. Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment [ Time Frame: 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 :

1. Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Pakistan
Site Ref # / Investigator 54037
Peshawar, KP, Pakistan
Site Ref # / Investigator 54044
Multan, Punjab, Pakistan, 60000
Site Ref # / Investigator 54026
Faisalabad, Pakistan
Site Ref # / Investigator 54028
Faisalabad, Pakistan
Site Ref # / Investigator 54029
Faisalabad, Pakistan
Site Ref # / Investigator 54015
Hyderabad, Pakistan
Site Ref # / Investigator 54016
Hyderabad, Pakistan
Site Ref # / Investigator 54017
Hyderabad, Pakistan
Site Ref # / Investigator 54018
Hyderabad, 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

Sponsors and Collaborators

Abbott

Investigators

Study Director:	Raeef Ahmed, MD	Abbott

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01354938 History of Changes
Other Study ID Numbers:	P12-822
First Posted:	May 17, 2011
Results First Posted:	January 30, 2013
Last Update Posted:	February 6, 2013
Last Verified:	February 2013

Keywords provided by Abbott:

Bronchitis

Additional relevant MeSH terms:

Bronchitis; Acute Disease; Bronchitis, Chronic; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes	Pulmonary Disease, Chronic Obstructive; Clarithromycin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors