Trial Outcomes & Findings for Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis (NCT NCT01354938)

Last Updated: 2013-02-06

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

220 participants

Primary outcome timeframe

Baseline, End of Treatment (maximum treatment duration of 10 days)

Results posted on

2013-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	220
Overall Study COMPLETED	219
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=220 Participants 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.
Age Continuous	56.35 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	193 Participants n=5 Participants
Region of Enrollment Pakistan	220 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, End of Treatment (maximum treatment duration of 10 days)

Population: Participants with evaluable data

Outcome measures

Outcome measures
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=219 Participants 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.
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 20.0
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
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
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
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
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
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 21.0
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

PRIMARY outcome

Timeframe: Baseline, End of Treatment (maximum treatment duration of 10 days)

Population: Participants with evaluable data

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).

Outcome measures

Outcome measures
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=219 Participants 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.
Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment	176 participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=220 Participants 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.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any AE	12 participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any SAE	1 participants

Adverse Events

Acute Exacerbation of Chronic Bronchitis (AECB)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=220 participants at risk 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.
Skin and subcutaneous tissue disorders Stevens-Johnson Syndrome	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)

Other adverse events

Other adverse events
Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n=220 participants at risk 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.
Nervous system disorders Vertigo	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Nervous system disorders Headache	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Skin and subcutaneous tissue disorders Pruritis generalized	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Skin and subcutaneous tissue disorders Rash	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Gastrointestinal disorders Diarrhea	0.91% 2/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Gastrointestinal disorders Dysgeusia	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Gastrointestinal disorders Nausea	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Gastrointestinal disorders Decreased appetite	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Gastrointestinal disorders Abdominal pain upper	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Endocrine disorders Hypoglycaemia	0.45% 1/220 • From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)

Additional Information

Esther Oppermann, Clinical Trial Manager

Abbott

Phone: 49 511 6750 3954

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER