To investigate the safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid in stable COPD patients.Secondary Objective(s): To investigate the amoxicillin levels obtained in sputum and serum
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: safety and tolerability of inhalation of nebulized amoxicillin
clavulanic acid, as determined by spirometry and adverse effects monitoring.
Secondary outcome
Secondary: dose exposure data as determined by sputum and serum concentrations
of amoxicillin
Background summary
Previous research has shown that an amoxicillin concentration higher than the
Minimal Inhibiting Concentration of 90% (MIC90) reduced the mean length of
hospitalization during a COPD exacerbation from 11 to 7 days.[19] Furthermore
most patients did not reach amoxicillin levels equal or higher than the Minimal
Inhibiting Concentration of 90% (MIC90) when amoxicillin clavulanic acid was
administered orally or intravenously [19,20]. We hypothesize that more patients
will achieve an adequate amoxicillin level in sputum when amoxicillin
clavulanic acid is administered locally instead of systemic. Therefore we want
to apply nebulized amoxicillin clavulanic acid by inhalation. In this study we
want to investigate the safety and tolerability of nebulized amoxicillin
clavulanic acid administered by inhalation in COPD patients
Study objective
To investigate the safety and tolerability of inhalation of nebulized
amoxicillin clavulanic acid in stable COPD patients.
Secondary Objective(s): To investigate the amoxicillin levels obtained in
sputum and serum
Study design
The study is designed as a single-arm prospective intervention study
Intervention
Participating patients will receive treatment by inhalation of nebulized
amoxicillin clavulanic acid in four dosing steps
Study burden and risks
Risk: Aerosolized delivery of antimicrobial agents is an attractive option for
management of pulmonary infections, as this is an ideal method of providing
high local drug concentrations while minimizing systemic exposure. Inhalation
of nebulized amoxicillin clavulanic acid has not been described in literature.
There are only two studies on tolerability of inhalation of amoxicillin. In
these studies amoxicillin was well tolerated. However their sample sizes were
small. There are no signs to suspect tolerability issues in excess of those
encountered with systemic administration. Local adverse effects such as cough,
wheezing, shortness of breath, and respiratory irritation can occur with
aerosolized delivery of antimicrobials. Therefore security measures will be
taken. Benefit: Since this treatment is provided in stable state instead of
during a COPD exacerbation, no benefit for the participating patients is
expected
Haaksbergerstraat 55
7513 ER Enschede
NL
Haaksbergerstraat 55
7513 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
• • A clinical diagnosis of stable COPD, as defined by GOLD criteria;• Able to produce sputum;• Age 40 years or over ;• Current or former smoker.
Exclusion criteria
• Exacerbation or use of prednisolone or antibiotics related to an exacerbation 4 weeks prior to enrolment.;• Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a chest radiograph which was neither pre-existing nor of any other cause.;• Allergy for penicillin, amoxicillin or clavulanic acid.;• Respiratory insufficiency and hypercapnia measured by arterial blood gas analyses.;• FEV1 postbronchodilator< 1.2 l.
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 | EUCTR2011-004252-19-NL |
| CCMO | NL37727.044.11 |