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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01354938
First received: May 16, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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 Intervention
Bronchitis
Drug: Clarithromycin modified release 500 mg

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 220
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354938

Locations
Pakistan
Site Ref # / Investigator 54037
Peshawar, KP, Pakistan
Site Ref # / Investigator 54044
Multan, Punjab, Pakistan, 60000
Site Ref # / Investigator 54028
Faisalabad, Pakistan
Site Ref # / Investigator 54026
Faisalabad, Pakistan
Site Ref # / Investigator 54029
Faisalabad, Pakistan
Site Ref # / Investigator 54017
Hyderabad, Pakistan
Site Ref # / Investigator 54015
Hyderabad, Pakistan
Site Ref # / Investigator 54018
Hyderabad, Pakistan
Site Ref # / Investigator 54016
Hyderabad, Pakistan
Site Ref # / Investigator 54035
Islamabad, Pakistan
Site Ref # / Investigator 54007
Karachi, Pakistan
Site Ref # / Investigator 54013
Karachi, Pakistan
Site Ref # / Investigator 54010
Karachi, Pakistan
Site Ref # / Investigator 54009
Karachi, Pakistan
Site Ref # / Investigator 54006
Karachi, Pakistan
Site Ref # / Investigator 54005
Karachi, Pakistan
Site Ref # / Investigator 54004
Karachi, Pakistan
Site Ref # / Investigator 54003
Karachi, Pakistan
Site Ref # / Investigator 54002
Karachi, Pakistan
Site Ref # / Investigator 54019
Lahore, Pakistan
Site Ref # / Investigator 54023
Lahore, Pakistan
Site Ref # / Investigator 54020
Lahore, Pakistan
Site Ref # / Investigator 54022
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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01354938     History of Changes
Other Study ID Numbers: P12-822
Study First Received: May 16, 2011
Results First Received: December 20, 2012
Last Updated: February 1, 2013
Health Authority: Pakistan: Ministry of Health

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
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014