Trial · NCT01354938
Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis
NCT01354938, Completed, Abbott; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis. Trials, record NCT01354938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01354938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis
- NCT number
- NCT01354938
- Status
- Completed
- Enrollment
- 220 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Bronchitis
- Interventions
- Clarithromycin modified release 500 mg
- First posted
- 2011-05-17
- Last updated
- 2013-02-06
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | 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. |
| Primary | Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment | 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). |
| Secondary | 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) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Baseline, End of Treatment (maximum treatment duration of 10 days) | Participants with evaluable data | units on a scale | MEAN |
| SECONDARY | 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) | All enrolled participants | participants | NUMBER |
| PRIMARY | Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment | Baseline, End of Treatment (maximum treatment duration of 10 days) | Participants with evaluable data | participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Symptoms Score at Baseline | 69.6 | Standard Deviation 20.0 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Activity Score at Baseline | 67.4 | Standard Deviation 20.8 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Impacts Score at Baseline | 61.0 | Standard Deviation 22.6 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Total Score at Baseline | 64.5 | Standard Deviation 19.2 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Symptoms Score at End of Treatment | 43.7 | Standard Deviation 23.2 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Activity Score at End of Treatment | 51.8 | Standard Deviation 21.2 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Impacts Score at End of Treatment | 37.8 | Standard Deviation 21.0 | units on a scale |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment | Acute Exacerbation of Chronic Bronchitis (AECB) | Total Score at End of Treatment | 43.2 | Standard Deviation 18.9 | units on a scale |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Acute Exacerbation of Chronic Bronchitis (AECB) | Any AE | 12 | participants | |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Acute Exacerbation of Chronic Bronchitis (AECB) | Any SAE | 1 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Exacerbation of Chronic Bronchitis (AECB) | 220 | |
| Overall Study | COMPLETED | Acute Exacerbation of Chronic Bronchitis (AECB) | 219 | |
| Overall Study | NOT COMPLETED | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Nervous system disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Headache | Nervous system disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Pruritis generalized | Skin and subcutaneous tissue disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Rash | Skin and subcutaneous tissue disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Diarrhea | Gastrointestinal disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 2 | 220 | |
| other | Dysgeusia | Gastrointestinal disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Nausea | Gastrointestinal disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Decreased appetite | Gastrointestinal disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 | |
| other | Hypoglycaemia | Endocrine disorders | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Exacerbation of Chronic Bronchitis (AECB) | ||
| Total, other adverse events | Acute Exacerbation of Chronic Bronchitis (AECB) | 11 | 220 |
| Total, serious adverse events | Acute Exacerbation of Chronic Bronchitis (AECB) | 1 | 220 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01354938
GET https://conductscience.org/api/trials/v1/NCT01354938/registered