CompletedNot Applicable

Characterization of Aerosol Generation and Transport in the Human Lung

10 participantsStarted 2010-03

Plain-language summary

This study is aiming at evaluating whether the number and size of exhaled particles changes during the increase and decrease of bronchial constriction in subjects with mild intermittent asthma.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female subjects, aged 18 to 65 years.
✓. Physician diagnosis of mild intermittent allergic asthma (GINA I according to GINA guidelines9).
✓. Normal lung function parameters at baseline (FEV1 \> 80 % of predicted)
✓. Non smoker or smokers with a history of less than 10 pack years with no smoking in the last 12 months.
✓. Able and willing to give written informed consent
✓. Women will be considered for inclusion if they are:

Exclusion criteria

✕. History of lower respiratory tract infection four weeks prior to the informed consent visit.
✕. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
✕. Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements, and short acting beta mimetics (SABA) on as needed basis.
✕. Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks.
✕. Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
✕. Conditions or factors, which would make the subject unlikely to be able to undergo methacholine challenge.
✕. Conditions which provide a contraindication for methacholine challenge testing such as uncontrolled arterial hypertension, known aortic aneurysm, myocardial infarction or stroke within three months prior to study, current use of cholinesterase inhibitor medication.
✕. Inability to perform acceptable-quality spirometry.

What they're measuring

Exhaled breath analysis

Timeframe: Within one day

Trial details

NCT IDNCT01095627

SponsorFraunhofer-Institute of Toxicology and Experimental Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

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