Bronchitis
Conditions
Keywords
Bronchitis
Brief summary
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.
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.
Interventions
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.
Sponsors
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | 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. |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Acute Exacerbation of Chronic Bronchitis (AECB) |
|---|---|
| Age Continuous | 56.35 years STANDARD_DEVIATION 12 |
| Region of Enrollment Pakistan | 220 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 220 |
| serious Total, serious adverse events | 1 / 220 |
Outcome results
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).
Time frame: Baseline, End of Treatment (maximum treatment duration of 10 days)
Population: Participants with evaluable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Exacerbation of Chronic Bronchitis (AECB) | Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment | 176 participants |
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.
Time frame: Baseline, End of Treatment (maximum treatment duration of 10 days)
Population: Participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Impacts Score at Baseline | 61.0 units on a scale | Standard Deviation 22.6 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Symptoms Score at Baseline | 69.6 units on a scale | Standard Deviation 20 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Activity Score at Baseline | 67.4 units on a scale | Standard Deviation 20.8 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Total Score at Baseline | 64.5 units on a scale | Standard Deviation 19.2 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Symptoms Score at End of Treatment | 43.7 units on a scale | Standard Deviation 23.2 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Activity Score at End of Treatment | 51.8 units on a scale | Standard Deviation 21.2 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Impacts Score at End of Treatment | 37.8 units on a scale | Standard Deviation 21 |
| Acute Exacerbation of Chronic Bronchitis (AECB) | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Total Score at End of Treatment | 43.2 units on a scale | Standard Deviation 18.9 |
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.
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)
Population: All enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acute Exacerbation of Chronic Bronchitis (AECB) | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 12 participants |
| Acute Exacerbation of Chronic Bronchitis (AECB) | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 1 participants |