1. To test feasibility of mannitol inhalations in a Dutch pulmonary out-patient clinic.2. To compare time and costs involved in measuring airways hyperresponsiveness by methacholine to mannitol
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time involved in measurement of hyperresponsiveness (including technician time
for preparation and cleaning)
Secondary outcome
- Patient reported side effects
- Patient preference
- Technician preference
- Borg score during test
- BHR questionnaire (van der Molen 2005)
Background summary
Airway hyperresponsiveness (AHR) is an exaggerated increase in airflow
limitation following exposure to a non allergic stimulus. This can be tested
with either direct or indirect challenges.
The two typical examples of bronchoconstrictor agents for direct airway
challenges are histamine and methacholine. Cold air, dry air, and exercise
challenge tests all measure AHR in an indirect way. Examples of
bronchoconstrictor agents that are used for indirect challenges include
hypotonic saline, hypertonic saline, AMP and mannitol.
The respons to indirect stimuli as mannitol and AMP seems to be closely related
to airway inflammation and therefore may be a better suited to asses
therapeutic efficacy than direct challenges or patient reported symptoms.
Direct challenges are time consuming for site personnel and for patients.
Challenges with mannitol, a dry powder sugar alcohol, cost only 1.5 minutes per
dosing step and should therefore be quicker than methacholine, the current gold
standard, wich takes 5 minutes per dosing step. Also the preparation time
should be shorter with mannitol.
Study objective
1. To test feasibility of mannitol inhalations in a Dutch pulmonary out-patient
clinic.
2. To compare time and costs involved in measuring airways hyperresponsiveness
by methacholine to mannitol
Study design
The study is a randomised single blinded (patient blinded), cross-over study
Intervention
In random order two airway hyperreactivity test, methacholine and mannitol,
separated by at least 3 days.
Study burden and risks
Patients will have to come in one extra time for measuring of AHR and will be
asked to fill out a number of quesionnaires, this will take approximately 3
hours. Some of the patients medication will have to be stopped for a certain
amount of time (maximum of three days).
There are a number of side effect reported for AHR tests, namely cough, nausea,
wheezing, mild dyspnea and chest tightness. Serious adverse events have not
been reported.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Asthmatics:
- Episodic symptoms of dyspnea, and/or wheezing, and/or cough
- Allergic or non-allergic
- non current smokers (> 0.5 years)
- PC20 MCh < 8 mg/ml;COPD patients:
- Age > 40 yrs
- Active or former smokers, with a smoking history of more than 10 packyears
- Continuous symptoms of cough/sputum and/or dyspnea on exertion
- No history of asthma
- FEV1/FVC < 70 % and FEV1 between 50 and 80 % pred.;Controls
- No history of asthma or COPD
- PC20 MCh > 8 mg/ml
- FEV1/FVC > 70 % and FEV1 > 90 %pred.
Exclusion criteria
m- Age < 18 years
- Inability to perform acceptable-quality spirometry or to understand directions given by personnel
- Severe airflow limitation (FEV1 < 50% of predicted or < 1.0 L)
- Heart attack or stroke in last 6 months
- Uncontrolled hypertension, systolic BP > 200, or diastolic BP > 100
- Known aortic aneurysm
- Pregnancy
- Nursing mothers
- Current use of cholinesterase inhibitor medication (for myasthenia gravis)
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 | EUCTR2006-003795-35-NL |
| CCMO | NL22652.042.08 |