- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01095627
Characterization of Aerosol Generation and Transport in the Human Lung
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Mild Intermittent Allergic Asthma Before and After Methacholine Challenge
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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:
not pregnant, as confirmed by pregnancy test, and not nursing of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit) of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study -, implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
• Available to complete all study measurements
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.
- History of drug or alcohol abuse.
- Participation in another clinical trial 30 days prior to enrolment.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Risk of non-compliance with study procedures.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Metacholine Challenge
Exhaled breath analysis following metacholine challenge
|
Exhaled breath analysis following metacholine challenge
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exhaled breath analysis
Délai: Within one day
|
In ten subjects with mild intermittent allergic asthma particles in exhaled breath will be analyzed for their number and size in a time dependent manner before and after induction of bronchial obstruction by methacholine challenge.
|
Within one day
|
Collaborateurs et enquêteurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10/04 AEROB
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