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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354938
• Other study ID #: P12-822
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: February 1, 2013
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Pakistan, 

Outcome

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