Mannitol inhalations as faster procedure for testing of airways hyper-responsiveness

ISRCTN	ISRCTN72604310
DOI	https://doi.org/10.1186/ISRCTN72604310
Secondary identifying numbers	Griac001

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 28/11/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof H A M Kerstjens, MD, PhD
Scientific

Head Department of Respiratory Medicine
University Medical Center Groningen
Postbox 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3612357
Email	h.a.m.kerstjens@int.umcg.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen (Medical Ethical Committee University Medical Center Groningen), approval received on October 3rd 2006.
Health condition(s) or problem(s) studied	Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Intervention	Measurement of bronchial hyper-responsiveness with mannitol and methacholine.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mannitol and methacholine
Primary outcome measure	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 study start date	01/09/2006
Completion date	31/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	120
Key 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
Key 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)
Date of first enrolment	01/09/2006
Date of final enrolment	31/08/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Head Department of Respiratory Medicine

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of Respiratory Medicine
P.O. Box 30001
Groningen
9700RB
Netherlands

"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Industry

Pharmaxis Ltd.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan