Bronchitis Clinical Trial
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)
Verified date | February 2013 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Pakistan | 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 54044 | Multan | Punjab |
Pakistan | Site Ref # / Investigator 55270 | Multan | |
Pakistan | Site Ref # / Investigator 54037 | Peshawar | KP |
Pakistan | Site Ref # / Investigator 55273 | Peshawar | |
Pakistan | Site Ref # / Investigator 54033 | Rawalpindi |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | 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. | Baseline, End of Treatment (maximum treatment duration of 10 days) | No |
Primary | Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment | 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). | Baseline, End of Treatment (maximum treatment duration of 10 days) | No |
Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | 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. | From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment) | Yes |
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