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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Q

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 Summary:

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.


Sponsor: Abbott

Current Primary Outcome:

  • 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.
  • 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).


Original Primary Outcome: St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 7 to 10 days ]

Improvement of at least 4 points in the SGRQ score


Current Secondary Outcome: 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.


Original Secondary Outcome: Reporting of any adverse event [ Time Frame: 7 to 10 days of treatment ]

Information By: Abbott

Dates:
Date Received: May 16, 2011
Date Started: May 2011
Date Completion:
Last Updated: February 1, 2013
Last Verified: February 2013