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
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Condition or disease | Intervention/treatment |
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Bronchitis | Drug: Clarithromycin modified release 500 mg |
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 |
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 |

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.
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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.
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- 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).
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354938
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 |
Study Director: | Raeef Ahmed, MD | Abbott |
Responsible Party: | Abbott |
ClinicalTrials.gov Identifier: | NCT01354938 History of Changes |
Other Study ID Numbers: |
P12-822 |
First Posted: | May 17, 2011 Key Record Dates |
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 |