NCT01354938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

May 16, 2011

Results QC Date

December 20, 2012

Last Update Submit

February 1, 2013

Conditions

Bronchitis

Keywords

Bronchitis

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • 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)

Study Arms (1)

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.

Drug: Clarithromycin modified release 500 mg

Interventions

Clarithromycin modified release 500 mgDRUG

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.

Acute Exacerbation of Chronic Bronchitis (AECB)

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Site Ref # / Investigator 54037

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Site Ref # / Investigator 54044

Multan, Punjab Province, 60000, Pakistan

Location

Site Ref # / Investigator 54026

Faisalabad, Pakistan

Location

Site Ref # / Investigator 54028

Faisalabad, Pakistan

Location

Site Ref # / Investigator 54029

Faisalabad, Pakistan

Location

Site Ref # / Investigator 54015

Hyderābād, Pakistan

Location

Site Ref # / Investigator 54016

Hyderābād, Pakistan

Location

Site Ref # / Investigator 54017

Hyderābād, Pakistan

Location

Site Ref # / Investigator 54018

Hyderābād, Pakistan

Location

Site Ref # / Investigator 54035

Islamabad, Pakistan

Location

Site Ref # / Investigator 54002

Karachi, Pakistan

Location

Site Ref # / Investigator 54003

Karachi, Pakistan

Location

Site Ref # / Investigator 54004

Karachi, Pakistan

Location

Site Ref # / Investigator 54005

Karachi, Pakistan

Location

Site Ref # / Investigator 54006

Karachi, Pakistan

Location

Site Ref # / Investigator 54007

Karachi, Pakistan

Location

Site Ref # / Investigator 54009

Karachi, Pakistan

Location

Site Ref # / Investigator 54010

Karachi, Pakistan

Location

Site Ref # / Investigator 54013

Karachi, Pakistan

Location

Site Ref # / Investigator 54019

Lahore, Pakistan

Location

Site Ref # / Investigator 54020

Lahore, Pakistan

Location

Site Ref # / Investigator 54022

Lahore, Pakistan

Location

Site Ref # / Investigator 54023

Lahore, Pakistan

Location

Site Ref # / Investigator 54040

Multan, Pakistan

Location

Site Ref # / Investigator 54043

Multan, Pakistan

Location

Site Ref # / Investigator 55270

Multan, Pakistan

Location

Site Ref # / Investigator 55273

Peshawar, Pakistan

Location

Site Ref # / Investigator 54033

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Results Point of Contact

Title
Esther Oppermann, Clinical Trial Manager
Organization
Abbott
49 511 6750 3954

Study Officials

  • Raeef Ahmed, MD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 6, 2013

Results First Posted

January 30, 2013

Record last verified: 2013-02

Locations

PA(28)