Contact information
Type
Scientific
Primary contact
Prof H A M Kerstjens, MD, PhD
ORCID ID
Contact details
Head Department of Respiratory Medicine
University Medical Center Groningen
Postbox 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3612357
h.a.m.kerstjens@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Griac001
Study information
Scientific title
Acronym
Study 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.
Ethics approval
Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen (Medical Ethical Committee University Medical Center Groningen), approval received on October 3rd 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Intervention
Measurement of bronchial hyper-responsiveness with mannitol and methacholine.
Intervention type
Drug
Phase
Not Specified
Drug names
Mannitol and methacholine
Primary outcome measures
Time involved in measurement of hyper-responsiveness (including technician time for preparation and cleaning).
Secondary outcome measures
1. Patient reported adverse events.
2. Patient preference.
3. Technician preference.
4. Borg score during test.
5. Exhaled Breath Condensate (EBC).
6. Bronchial Hyper-Reactivity questionnaire (BHR)
Overall trial start date
01/09/2006
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Asthmatics:
1. Episodic symptoms of dyspnea, and/or wheezing, and/or cough
2. Allergic or non-allergic
3. Non current smokers (more than 0.5 years)
4. Provocation Concentration that causes a decrease in forced expiratory volume in one second of 20% (PC20) for MethaCholine (MCh) less than 8 mg/ml
Chronic Obstructive Pulmonary Disease (COPD) patients:
1. Age more than 40 years
2. Active or former smokers, with a smoking history of more than ten pack years
3. Continuous symptoms of cough/sputum and/or dyspnea on exertion
4. No history of asthma
5. Forced expiratory volume in one second (FEV1)/Forced Vital Capacity (FVC) less than 70% and FEV1 between 50 and 80% predicted
Controls:
1. No history of asthma or COPD
2. PC20 MCh more than 8 mg/ml
3. FEV1/FVC more than 70% and FEV1 more than 90% predicted
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
1. Age less than 18 years
2. Inability to perform acceptable-quality spirometry or to understand directions given by personnel
3. Severe airflow limitation (FEV1 less than 50% of predicted or less than 1.0 L)
4. Heart attack or stroke in last three months
5. Uncontrolled hypertension, systolic Blood Pressure (BP) more than 200 mmHg, or diastolic BP more than 100 mmHg
6. Known aortic aneurysm
7. Pregnancy
8. Nursing mothers
9. Current use of cholinesterase inhibitor medication (for myasthenia gravis)
Recruitment start date
01/09/2006
Recruitment end date
31/08/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Head Department of Respiratory Medicine
Groningen
9700 RB
Netherlands
Funders
Funder type
Industry
Funder name
Pharmaxis Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary