To determin the effect of low dose azithromycin ( 3 times a week 250 mg) on the cough related health status in patients with COPD and chronic productive cough.In a randomized controlled study.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
LCQ (leicester cough questionnaire)
Secondary outcome
Short form 36, SGRQ.
FEV1, VC (spirometry), inflammatory markers sputum, microbiology sputum.
Background summary
In patients with COPD, chronic productive cough is a major symptom that can be
resistent to the usual medication and smoking cessation. The productive
coughing certainly has an influence on the quality of life, but possibly also
contributes to a worse outcome by an ongoing inflammatory proces. In our
hospital patient with chronic productive coughing are sometimes prescribed
Azithromycin in a low dose, with surprisingly good effect . In other
inflammatory pulmonal diseases like CF, diffuse panbronchiolitis and
bronchiectasis the effect of Azithromycin on the inflammatory effect has
allready been investigated and confirmed.
There is no randomized controlled study on the effect on COPD.
Study objective
To determin the effect of low dose azithromycin ( 3 times a week 250 mg) on the
cough related health status in patients with COPD and chronic productive cough.
In a randomized controlled study.
Study design
At least 84 pat. with COPD gold 2-4 in our outpatient clinic with chronic
productive cough ( more than 3 months a year , two subseguent years) will be
randomized, double blind to a therapy low dose azithromycin or placebo for 12
weeks.
The effect of this therapy will be measured by questionnaires on cough-related
quality of life, the LCQ (leicester cough questionnaire), short form 36 and
the SGRQ ( st George questionnaire) will be used.
A spirometry will be done before and after 12 weeks and a sputum analyses on
inflammatory markers and bacteria.
Study burden and risks
The risk of participation is low. Azithromycin is a frequently used antibiotic
without SUSAR's (except for infrequent allergic reactions) and is given here in
a low dose.
Groot Weezenland 20
8011 JW Zwolle
NL
Groot Weezenland 20
8011 JW Zwolle
NL
Listed location countries
Age
Inclusion criteria
1. Patients > 40 years old, in our outpatient clinic with chronic cough and COPD (gold 2-4).
2. Chronic cough is defined as a cough > 12 weeks duration, 2 years in a row.
3. Analysed for bronchiectasis prior to participation.
Exclusion criteria
1. Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion
2. Patients suffering from other relevant lung diseases.
3. Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
4. Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal).
5. Pregnancy or lactation.
6. Use of macrolides the last 6 weeks prior to inclusion.
7. Allergy or intolerance to macrolides.
8. Other research medication started 2 months prior to inclusion.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000800-96-NL |
| CCMO | NL19886.075.08 |