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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2321 |
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Date of registration:
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11/05/2010 |
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Primary sponsor: |
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Public title:
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Breath testing for asthma and COPD.
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Scientific title:
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The diagnostic accuracy of exhaled breath fingerprinting by eNose for asthma and COPD in patients with an intention to diagnose. - IDeNose |
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Date of first enrolment:
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17/5/2010 |
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Target sample size:
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80 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2321 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Niki
Fens |
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Address:
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Clinical Research Fellow 'Electronic Nose'
Academic Medical Center (AMC)
University of Amsterdam
Department of Pulmonology
F5-260
P.O.Box 22660, Meibergdreef 9
1100 DD
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5664359 |
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Email:
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N.Fens@amc.nl |
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Affiliation:
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Name:
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Niki
Fens |
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Address:
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Clinical Research Fellow 'Electronic Nose'
Academic Medical Center (AMC)
University of Amsterdam
Department of Pulmonology
F5-260
P.O.Box 22660, Meibergdreef 9
1100 DD
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5664359 |
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Email:
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N.Fens@amc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients (>16 years old) getting a diagnostic work-up for asthma or COPD in the Academic Medical Centre (Amsterdam) will be included in the study;
2. Differential diagnosis of asthma, COPD, obstructive lung disease;
3. Clinical evaluation for reversibility (FEV1), airway hyperresponsiveness, airway obstruction.
Exclusion criteria: Known current diagnosis of asthma and/or COPD.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Asthma, COPD, STARD, Diagnostic accuracy
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Intervention(s)
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Electronic nose: The Cyranose 320 (Smith Detections, Pasadena, Ca, USA), a handheld portable chemical vapor analyzer, containing a nanocomposite sensor array with 32 polymer sensors. Patients will breathe normally through a mouthpiece, connected to a three-way non-re-breathing valve and an inspiratory VOC-filter (A2, North Safety, NL) for 5 minutes. After a single deep inspiration the patient exhales a vital capacity volume into a Tedlar bag connected to the expiratory port. Within 30 minutes the electronic nose will be connected to the Tedlar bag, followed by 1 minute sampling of the exhaled air.
Diagnostic work-up for asthma or COPD.
According to usual care.
At least pre-bronchodilator spirometry and symptoms.
Skin prick test/RAST: Allergy testing.
Spirometry: Pre- and postbronchodilator spirometry according to ERS/ATS recommendations.
Exhaled NO: Using the Niox Aerocrine or Niox Mino according to the ATS recommendations (ATS NO).
Bronchial responsiveness by histamine or methacholine challenge according to ERS/ATS recommendations.
Symptoms: Questionnaires for assessing symptoms of asthma and COPD and for co-morbidity will be used.
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Primary Outcome(s)
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The primary outcome parameter is the breathprint provided by the electronic nose.
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Secondary Outcome(s)
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1. FEV1;
2. Reversibility in FEV1;
3. PC20 airway hyperresponsiveness;
4. Respiratory symptoms.
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Source(s) of Monetary Support
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Netherlands Asthma Foundation
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