N/A
N=220
Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis
Bronchitis
Bottom Line
View on ClinicalTrials.gov: NCT01354938 ↗Enrolled (actual)
220
Serious AEs
0.4%
Results posted
Jan 2013
Primary outcome: Primary: St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment — 69.6; 67.4; 61.0; 64.5 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Clarithromycin modified release 500 mg (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment |
69.6; 67.4; 61.0; 64.5; 43.7; 51.8 | — |
| PRIMARY Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment |
176 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) |
12; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01354938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.