Clinical trial NCT01354938: Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis
Keywords: Bronchitis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 220
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

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.

Eligibility criteria: 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

Primary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment
timeFrame: Baseline, End of Treatment (maximum treatment duration of 10 days)
measure: Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment
timeFrame: Baseline, End of Treatment (maximum treatment duration of 10 days)
Secondary outcomes:
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Site Ref # / Investigator 54037
state: KP
city: Multan
country: Pakistan
facility: Site Ref # / Investigator 54044
state: Punjab
city: Faisalabad
country: Pakistan
facility: Site Ref # / Investigator 54026
city: Faisalabad
country: Pakistan
facility: Site Ref # / Investigator 54028
city: Faisalabad
country: Pakistan
facility: Site Ref # / Investigator 54029
city: Hyderabad
country: Pakistan
facility: Site Ref # / Investigator 54015
city: Hyderabad
country: Pakistan
facility: Site Ref # / Investigator 54016
city: Hyderabad
country: Pakistan
facility: Site Ref # / Investigator 54017
city: Hyderabad
country: Pakistan
facility: Site Ref # / Investigator 54018
city: Islamabad
country: Pakistan
facility: Site Ref # / Investigator 54035
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54002
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54003
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54004
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54005
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54006
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54007
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54009
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54010
city: Karachi
country: Pakistan
facility: Site Ref # / Investigator 54013
city: Lahore
country: Pakistan
facility: Site Ref # / Investigator 54019
city: Lahore
country: Pakistan
facility: Site Ref # / Investigator 54020
city: Lahore
country: Pakistan
facility: Site Ref # / Investigator 54022
city: Lahore
country: Pakistan
facility: Site Ref # / Investigator 54023
city: Multan
country: Pakistan
facility: Site Ref # / Investigator 54040
city: Multan
country: Pakistan
facility: Site Ref # / Investigator 54043
city: Multan
country: Pakistan
facility: Site Ref # / Investigator 55270
city: Peshawar
country: Pakistan
facility: Site Ref # / Investigator 55273
city: Rawalpindi
country: Pakistan
facility: Site Ref # / Investigator 54033
Study officials:
affiliation: Abbott
name: Raeef Ahmed, MD
role: STUDY_DIRECTOR
References: