The aim of this study is to compare the PD20 values measured with the Vilbiss 646 jet nebulizer protocol and with the MedicAid nebulizing protocol in 20 subjects with respiratory symptoms suggestive of bronchial hyperreactivity.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The severity of AHR can be expressed in de amount of metacholine dosage in
miligram that causes a 20% fall in FEV1, known as the PD20.
Secondary outcome
Not applicable
Background summary
Bronchial provocation tests (BPTs) are used to detect the presence and severity
of airway hyperresponsiveness (AHR) in patients with respiratory symptoms that
are suspected of having asthma. In these tests nebulized methacholine is
administered to a subject until a fall in forced expiratory volume in one
second (FEV1) >= 20% is established. The severity of airway hyper-responsiveness
can be expressed as the dose of methacholine that causes a 20% fall FEV1, known
as the PD20.
Several methods to administer methacholine are currently available. In the
dosimeter method, methacholine is inhaled during a specific number of deep
breaths. Our department now uses the aged DeVilbiss 646 jet nebulizer in
combination with nebulization schema of increasing concentrations. New
techniques like the MedicAid jet nebulizer are used in combination with a
dosage schema of increasing number of puffs with a constant concentration. By
validating the new nebulization technique is the pulmonary medicine department
able to switch to a new nebulizer device for the future BPTs, which offers a
more effective way of obtaining and processing data.
Study objective
The aim of this study is to compare the PD20 values measured with the Vilbiss
646 jet nebulizer protocol and with the MedicAid nebulizing protocol in 20
subjects with respiratory symptoms suggestive of bronchial hyperreactivity.
Study design
The design of this study will be a single randomised crossover centre study at
the Medisch Spectrum Twente, Enschede.
Intervention
Participating subjects will perform two times a bronchial provocation test
(BPT). Subjects will be randomly divided into two groups. Group one will
measure first with the DeVilbiss 646 jet nebulizer and then with the MedicAid
jet nebulizer. In the other group is the nebulizer order reversed.
Study burden and risks
A bronchial provocation test can induce some respiratory symptoms, such as
coughing, hoarseness and shortness of breath. This however, is the concept of
the BPT so that the severity of AHR could be evaluated. To treat respiratory
symptoms caused by metacholine induced bronchospasmes, a bronchodilator is
given at the end of the provocation test. A subject will leave the deparment
afther the test without serious complains. The risk for adverse events in this
study is negligible. The currently used provocation protocol is conducted for
years without occurrence of any (serious) adverse events. The new nebulizer
protocol follows the same safety procedures as the known DeVilbiss 646 jet
nebulizer protocol. The cumulated dosage metacholine is of the same amount with
both nebulizers. The amount of metacholine is calculated with the known
histamine protocol and is expressed on molar base.
Broerstraat 5
9712 CP Groningen
Nederland
Broerstraat 5
9712 CP Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Symptoms off bronchial hyper-reactivity.
Positive provocation test (PD20).
Exclusion criteria
Recent use of oral or inhaled bronchodilators
Severe airways obstruction at baseline (FEV1 < 1.2 liter)
FEV1 < 50% of the reference value
Recent myocardial infarction (< 3 months)
Recent cerebral vascular accident (< 3 months)
Known arterial aneurysmata
Inability to understand the procedures and the implication of a challenge test
Spirometry-induced airway obstruction
Moderate to severe airway obstruction (e.g. predicted value: male: predicted FEV1 minus 1.5 liter or female: predicted FEV1 minus 1.2 liter)
FEV1 < 65% of the reference value and FEV1 < 2 liter
Recent upper respiration tract infection (< 2 weeks)
During exacerbation of asthma
Hypertension: systolic blood pressure > 200 mmHg or diastolic pressure > 100 mmHg
Pregnancy
Epilepsia dependent on medication
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 |
|---|---|
| CCMO | NL29255.044.09 |