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Mannitol inhalations as faster procedure for testing of airways hyperresponsiveness.


- candidate number2221
- NTR NumberNTR756
- ISRCTNISRCTN72604310
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR29-aug-2006
- Secondary IDsGriac001 
- Public TitleMannitol inhalations as faster procedure for testing of airways hyperresponsiveness.
- Scientific TitleMannitol inhalations as faster procedure for testing of airways hyperresponsiveness.
- ACRONYMN/A
- hypothesisMeasurement 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) studiedChronic Obstructive Pulmonary Disease (COPD), Asthma, COPD
- Inclusion criteriaAsthmatics:
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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate31-aug-2007
- Target number of participants120
- InterventionsMeasurement of bronchial hyperresponsiveness with mannitol and methacholine.
- Primary outcomeTime involved in measurement of hyperresponsiveness (including technician time for preparation and cleaning).
- Secondary outcome1. 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)
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. E.D. Telenga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.A.M. Kerstjens
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Respiratory Medicine
- Funding
(Source(s) of Monetary or Material Support)
Pharmaxis Pharmaceuticals Limited
- PublicationsPlanned
- Brief summaryAirway 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)
- RECORD29-aug-2006 - 9-dec-2009


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