No registrations found.
ID
Source
Brief title
Health condition
Asthma, COPD, subjects without airways hyperresponsiveness
Sponsors and support
University Medical Center Groningen
Postbox 30.001
9700RB Groningen
the Netherlands
2/10 Rodborough Rd, Frenchs Forest NSW 2086
Australia
Intervention
Outcome measures
Primary outcome
Time involved in measurement of hyperresponsiveness (including technician time for preparation and cleaning).
Secondary outcome
1. Patient reported adverse events.
2. Patient preference.
3. Technician preference.
4. Borg score during test.
5. Exhaled breath condensate (EBC).
6. Bronchial Hyperreactivity questionnaire (BHR, van der Molen 2005)
Background summary
Airway hyperresponsiveness (AHR) can be measured with direct (histamine or methacholine) and indirect agents (AMP, hypertonic saline, excercise and mannitol). We believe that measurement of airways hyperresponsiveness by mannitol (Aridol©) as compared to methacholine saves time to the lung function technician, while being as sensitive to discern hyperresponsive from normo-responsive. We will assess the saved time in this randomised, single-blinded, cross-over study.
Study objective
Measurement of airways hyperresponsiveness by mannitol (Aridol©) as compared to methacholine saves time to the lung function technician, while being as sensitive to discern hyperresponsive from normo-responsive, and being at least equally acceptable to patients presenting at a pulmonary out-patient clinic.
Study design
N/A
Intervention
Measurement of bronchial hyperresponsiveness with mannitol and methacholine.
Department of Respiratory Medicine
Hanzeplein 1
Postbox 30.001
E.D. Telenga
Groningen 9700 RB
The Netherlands
+31 (0)50 3619505
E.D.Telenga@int.umcg.nl
Department of Respiratory Medicine
Hanzeplein 1
Postbox 30.001
E.D. Telenga
Groningen 9700 RB
The Netherlands
+31 (0)50 3619505
E.D.Telenga@int.umcg.nl
Inclusion criteria
Asthmatics:
1. Episodic symptoms of dyspnea, and/or wheezing, and/or cough.
2. Allergic or non-allergic.
3. non current smokers (> 0.5 years).
4. PC20 MCh < 8 mg/ml
COPD patients:
1. Age > 40 yrs.
2. Active or former smokers, with a smoking history of more than 10 packyears.
3. Continuous symptoms of cough/sputum and/or dyspnea on exertion.
4. No history of asthma.
5. FEV1/FVC < 70 % and FEV1 between 50 and 80 % pred.
Controls:
1. No history of asthma or COPD;
2. PC20 MCh > 8 mg/ml;
3. FEV1/FVC > 70 % and FEV1 > 90 %pred.
Exclusion criteria
1. Age < 18 years.
2. Inability to perform acceptable-quality spirometry or to understand directions given by personnel.
3. Severe airflow limitation (FEV1 < 50% of predicted or < 1.0 L).
4. Heart attack or stroke in last 3 months.
5. Uncontrolled hypertension, systolic BP > 200, or diastolic BP > 100.
6. Known aortic aneurysm.
7. Pregnancy.
8. Nursing mothers.
9. Current use of cholinesterase inhibitor medication (for myasthenia gravis).
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 |
|---|---|
| NTR-new | NL746 |
| NTR-old | NTR756 |
| Other | : Griac001 |
| ISRCTN | ISRCTN72604310 |