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

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ClinicalTrials.gov Identifier: NCT01354938
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : January 30, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Bronchitis
Intervention Drug: Clarithromycin modified release 500 mg
Enrollment 220
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 220
Completed 219
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 220
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 220 participants
56.35  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants
Female
27
  12.3%
Male
193
  87.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Pakistan Number Analyzed 220 participants
220
1.Primary Outcome
Title St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment
Hide Description 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.
Time Frame Baseline, End of Treatment (maximum treatment duration of 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptoms Score at Baseline 69.6  (20.0)
Activity Score at Baseline 67.4  (20.8)
Impacts Score at Baseline 61.0  (22.6)
Total Score at Baseline 64.5  (19.2)
Symptoms Score at End of Treatment 43.7  (23.2)
Activity Score at End of Treatment 51.8  (21.2)
Impacts Score at End of Treatment 37.8  (21.0)
Total Score at End of Treatment 43.2  (18.9)
2.Primary Outcome
Title Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment
Hide Description 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).
Time Frame Baseline, End of Treatment (maximum treatment duration of 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 219
Measure Type: Number
Unit of Measure: participants
176
3.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Any AE 12
Any SAE 1
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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acute Exacerbation of Chronic Bronchitis (AECB)
Hide Arm/Group Description 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.
All-Cause Mortality
Acute Exacerbation of Chronic Bronchitis (AECB)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acute Exacerbation of Chronic Bronchitis (AECB)
Affected / at Risk (%)
Total   1/220 (0.45%) 
Skin and subcutaneous tissue disorders   
Stevens-Johnson Syndrome * 1  1/220 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acute Exacerbation of Chronic Bronchitis (AECB)
Affected / at Risk (%)
Total   11/220 (5.00%) 
Endocrine disorders   
Hypoglycaemia * 1  1/220 (0.45%) 
Gastrointestinal disorders   
Diarrhea * 1  2/220 (0.91%) 
Dysgeusia * 1  1/220 (0.45%) 
Nausea * 1  1/220 (0.45%) 
Decreased appetite * 1  1/220 (0.45%) 
Abdominal pain upper * 1  1/220 (0.45%) 
Nervous system disorders   
Vertigo * 1  1/220 (0.45%) 
Headache * 1  1/220 (0.45%) 
Skin and subcutaneous tissue disorders   
Pruritis generalized * 1  1/220 (0.45%) 
Rash * 1  1/220 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Esther Oppermann, Clinical Trial Manager
Organization: Abbott
Phone: 49 511 6750 3954
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01354938     History of Changes
Other Study ID Numbers: P12-822
First Submitted: May 16, 2011
First Posted: May 17, 2011
Results First Submitted: December 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: February 6, 2013