Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin modified release 500 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Primary care
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raeef Ahmed, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 54037 | Peshawar | Khyber Pakhtunkhwa | Pakistan | |||
| Site Ref # / Investigator 54044 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment) |
| Multan |
| Punjab Province |
| 60000 |
| Pakistan |
| Site Ref # / Investigator 54026 | Faisalabad | Pakistan |
| Site Ref # / Investigator 54028 | Faisalabad | Pakistan |
| Site Ref # / Investigator 54029 | Faisalabad | Pakistan |
| Site Ref # / Investigator 54015 | Hyderābād | Pakistan |
| Site Ref # / Investigator 54016 | Hyderābād | Pakistan |
| Site Ref # / Investigator 54017 | Hyderābād | Pakistan |
| Site Ref # / Investigator 54018 | Hyderābād | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with evaluable data | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Treatment (maximum treatment duration of 10 days) |
|
|
| |||||||||||||||||||||||||||||||||||
| 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. | All enrolled participants | Posted | Number | participants | From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment) |
|
| |||||||||||||||||||||||||||||||||||||
| 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). | Participants with evaluable data | Posted | Number | participants | Baseline, End of Treatment (maximum treatment duration of 10 days) |
|
|
From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 220 | 11 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stevens-Johnson Syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pruritis generalized | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Decreased appetite | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Endocrine disorders | MedDRA 14.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Oppermann, Clinical Trial Manager | Abbott | 49 511 6750 3954 |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Total Score at Baseline |
|
| Symptoms Score at End of Treatment |
|
| Activity Score at End of Treatment |
|
| Impacts Score at End of Treatment |
|
| Total Score at End of Treatment |
|
|
|
|