The aim of this study is to determine the optimal particle size of dry powder adenosine to assess small airway involvement in asthma. Secondary, to provide insight in the associations between the standard test, executed with nebulized AMP, and the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The major endpoint of the study is the change in small airways resistance
during the provocation tests, clarified as R5-R20 measured with IOS (impulse
oscillometry). Other endpoints of this study are the decline in FVC at 20% fall
in FEV1, and the PD20/PC20 values.
Secondary outcome
Other endpoints of this study are the decline in FVC at 20% fall in FEV1, and
the PD20/PC20 values.
Background summary
Asthma is a frequently occurring inflammatory lung disease that affects the
whole bronchial tree including the small airways (<2mm). Since the introduction
of the solution hydrofluoroalkane (HFA) technology it is possible to generate
medication with small particles of approximately 1-2 µm, and therefore to reach
the small airways. However, at this moment we have no reliable instruments to
identify the asthmatic subjects who particularly benefit from treatment with
inhaled small particles. Recently our research group investigated whether
provocation with small and large particles AMP is able to identify responders
and non-responders to treatment with small and large particles of inhaled
corticosteroids. This provocation technique gave promising results but needs
further optimization.
Study objective
The aim of this study is to determine the optimal particle size of dry powder
adenosine to assess small airway involvement in asthma. Secondary, to provide
insight in the associations between the standard test, executed with nebulized
AMP, and the new test, executed with dry powder Adenosine.
Study design
This is randomized cross-over study.
Intervention
Participating subjects perform 4 provocation tests in randomized order: one
time inhaling nebulized AMP, and four times dry powder adenosine. one test
contains small particles (MMAD 2,5-3mcm) and a slow inhalation (flow
20-30L/min), one test with small particles (MMAD 2,5-3mcm) and a fast
inhalation (flow 50-60Lmin), one test with large particles (MMAD 6-8mcm) and a
slow inhalation (flow 20-30L/min), one test with large particles (MMAD 6-8 mcm)
and fast inhalation (flow 50-60L/min). This is not a therapeutic intervention,
but a diagnostic procedure.
Study burden and risks
Asthma patients will spend a total of 6 visits in the hospital. The first visit
will take a maximum of 5 hours; the other visits will take approximately 2
hours. Risk associated with participation in the study is dyspnea during the
provocation tests and worsening of asthma symptoms because the
anti-inflammatory inhalation medication has to be quitted temporary.
Hanzeplein 1
9700 RB
NL
Hanzeplein 1
9700 RB
NL
Listed location countries
Age
Inclusion criteria
• A docter*s diagnosis of asthma
• Age: 18-65 years
• PC20 methacholine-bromide <= 4.9mg/ml
• Non-smoker
Exclusion criteria
• Steroid use 4 weeks before entry into the baseline period
• Recent exacerbation asthma (<2 months) or upper respiration tract infection (<2 weeks)
• Severe airway obstruction at baseline, FEV1pred < 50%or < 1.2L
• Diagnosis of COPD or any other pulmonary disease that could influence the study results as judged by the investigator
• Pregnancy or lactating women
Design
Recruitment
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 |
|---|---|
| Other | clinical trial nummer volgt |
| CCMO | NL37702.042.12 |