BronchitisNCT01354938

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

An observational study of Bronchitis, run by Abbott at 28 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Bronchitis
What is being tested?: Clarithromycin modified release 500 mg
Type of treatment: Pill or oral medicine
How many people: 220 participants
Where: 28 sitesPakistan
Study dates: May 2011to Jan 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Pakistan28 sites

Site Ref # / Investigator 54026
Faisalabad
Site Ref # / Investigator 54028
Faisalabad
Site Ref # / Investigator 54029
Faisalabad
Site Ref # / Investigator 54015
Hyderābād
Site Ref # / Investigator 54016
Hyderābād
Site Ref # / Investigator 54017
Hyderābād
Site Ref # / Investigator 54018
Hyderābād
Site Ref # / Investigator 54035
Islamabad
Site Ref # / Investigator 54002
Karachi
Site Ref # / Investigator 54003
Karachi
Site Ref # / Investigator 54004
Karachi
Site Ref # / Investigator 54005
Karachi
Site Ref # / Investigator 54006
Karachi
Site Ref # / Investigator 54007
Karachi
Site Ref # / Investigator 54009
Karachi
Site Ref # / Investigator 54010
Karachi
Site Ref # / Investigator 54013
Karachi
Site Ref # / Investigator 54019
Lahore
Site Ref # / Investigator 54020
Lahore
Site Ref # / Investigator 54022
Lahore
Site Ref # / Investigator 54023
Lahore
Site Ref # / Investigator 54044
Multan, Punjab Province, 60000
Site Ref # / Investigator 54040
Multan
Site Ref # / Investigator 54043
Multan
Site Ref # / Investigator 55270
Multan
Site Ref # / Investigator 54037
Peshawar, Khyber Pakhtunkhwa
Site Ref # / Investigator 55273
Peshawar
Site Ref # / Investigator 54033
Rawalpindi

Other trials in Pakistan

About this study

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)

Read the 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.

Conditions: Bronchitis
Being tested: Clarithromycin modified release 500 mg
Keywords: Bronchitis
Medical subject headings: Bronchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01354938
Study group	Role	What they receive
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. Receives: Drug: Clarithromycin modified release 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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)
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.
Measured: From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jan 2012

First posted17 May 2011 (estimated)
Study startMay 2011
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BronchitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01354938
Sponsor's protocol ID: P12-822
Status last verified: Feb 2013
First submitted: 16 May 2011
Last updated: 6 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bronchitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01354938
Acronym / sponsor ID: P12-822
Conditions: Bronchitis
Keywords: Bronchitis
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 17 May 2011 (estimated)
Results: Posted 30 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Acute Exacerbation of Chronic Bronchitis (AECB)	–	Drug: Clarithromycin modified release 500 mgParticipants 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.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clarithromycin modified release 500 mgClarithromycin 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.	Drug	Acute Exacerbation of Chronic Bronchitis (AECB)

Primary outcome

St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment
Time frame: 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
Time frame: 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).

1 secondary outcome

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
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)

Results and safety

Results posted to the registry on 30 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Exacerbation of Chronic Bronchitis (AECB)	220	219

Primary outcome: St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment

Time frame: Baseline, End of Treatment (maximum treatment duration of 10 days). Mean (Standard Deviation). Unit: units on a scale

Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n = 219
Symptoms Score at Baseline	69.6 (20.0)
Activity Score at Baseline	67.4 (20.8)
Impacts Score at Baseline	61.0 (22.6)
Total Score at Baseline	64.5 (19.2)
Symptoms Score at End of Treatment	43.7 (23.2)
Activity Score at End of Treatment	51.8 (21.2)
Impacts Score at End of Treatment	37.8 (21.0)
Total Score at End of Treatment	43.2 (18.9)

Population analysed: Participants with evaluable data

Primary outcome: Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment

Time frame: Baseline, End of Treatment (maximum treatment duration of 10 days). Number. Unit: participants

Measure	Acute Exacerbation of Chronic Bronchitis (AECB) n = 219
Value	176

Population analysed: Participants with evaluable data

1 secondary outcome is reported in the full results.

Adverse events

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). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Exacerbation of Chronic Bronchitis (AECB)	1 of 220 (0.5%)	11 of 220 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bronchitis

RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
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Active, not recruitingObservational study
Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD)
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Not yet recruitingPhase 4
Study to Evaluate the Effects of Oral Glyceryl Guiacolate (Guaifenesin, GGE) on Sputum Rheology in Subjects With Mucus Hypersecretion
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raeef Ahmed, MD study director

Abbott

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchitis, run by Abbott at 28 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment (time frame: Baseline, End of Treatment (maximum treatment duration of 10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01354938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013; AzTrials last refreshed its copy on 31 Oct 2026.