|- candidate number||2221|
|- NTR Number||NTR756|
|- Date ISRCTN created||22-nov-2006|
|- date ISRCTN requested||8-nov-2006|
|- Date Registered NTR||29-aug-2006|
|- Secondary IDs||Griac001 |
|- Public Title||Mannitol inhalations as faster procedure for testing of airways hyperresponsiveness.|
|- Scientific Title||Mannitol inhalations as faster procedure for testing of airways hyperresponsiveness.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Asthma, COPD|
|- 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
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.
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.
8. Nursing mothers.
9. Current use of cholinesterase inhibitor medication (for myasthenia gravis).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2007|
|- planned closingdate||31-aug-2007|
|- Target number of participants||120|
|- Interventions||Measurement of bronchial hyperresponsiveness with mannitol and methacholine.|
|- 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)
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. E.D. Telenga|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.A.M. Kerstjens|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Respiratory Medicine|
(Source(s) of Monetary or Material Support)
|Pharmaxis Pharmaceuticals Limited|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||29-aug-2006 - 9-dec-2009|