Condition category
Respiratory
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
28/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes