With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigateā¦
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FIV1
Secondary outcome
IC
Background summary
The correlation between de intensity of dyspnea and the expiratory pulmonary
lung function parameters, for instance the FEV1, in subjects with a stable
COPD, is poor. According to Taube et al, AMJRCCM 2000 vol 162 p 216-220, the
correlation between the inspiratory lung function parameter FIV1 is better.
Study objective
With intervention with bronchodilators (usual care bronchodilators for COPD
subjects), in one study histamine and in one study steroids, we want to
investigate the respons on inspiratory lung function parameter like the FIV1
and also investigate with the VAS score what the respons is on the intensity of
dyspnea.
Study design
The investigation is done in subjects with a stable COPD. It is a double-blind
randomised study (see protocols 1A -1E)
For study 1A the subjects have to come on 3 different days(within 2 weeks) at
the policlinic for lung function performance. A long function performance last,
with usual care COPD bronchodilator, 30 minutes up to a maximum of 1 hour.
Study 1A-1D last maximum for 1 hour.
For study 1e subject have to visit the us for 7 different days en perform each
time lung function which can last for a maximum of 2 hour.
Intervention
All studies are done in subjects witha stable COPD. The main parameter for
investigation is FIV1.
study 1A is done with with only once usual care Copd bronchodilators (atrovent
aerosol, ventolin aerosol en placebo aerosol), each on three different days.
Study 1B is done with only once inhalation of histamine (ERS criteria)
Study 1C is the effect of pursed lips breathing on the inspiratory lung
function parameters.
Study 1D is the done with once inhalation of Combivent via aerosol or with a
jet inhaler device
Study 1E is short term effect of corticosteroid, serevent and spiriva on the
inspiratory lung function parameter
Study burden and risks
low risk
weg door jonkerbos 100
6532 sz Nijmegen
Nederland
weg door jonkerbos 100
6532 sz Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
subjects with a stable COPD, mentally normal and with age between 40 end 75 years.
Exclusion criteria
heart diseases, subjects who used systemic corticosteroids less than 2 months ago, diseases which interfere with pulmonary lung function. Astma. Age < 40 years or > 75 years, mentally ill subjects. Subjects with pulmonary malignancy or neuromusculair diseases.
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 | EUCTR2006-001908-37-NL |
CCMO | NL11858.091.06 |