Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles

MCH NEB-1

A comparison of three nebulizers for standard clinical and research use in methacholine challenge testing
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT02822859
Asthma
Recrutement fermé
Dernière modification : 2017/10/23

Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Asthma

Source : Importé depuis le centre

Profil des participants

Donnée non disponible

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Men and women aged 18 or older
* Stable asthma
* Baseline methacholine PC20 less than or equal to 16mg/mL
* Baseline lung function greater than 65% predicted

Exclusion Criteria:

* Use of long-acting bronchodilators within 30 days of Visit 1
* Pregnant or nursing
* Cardiovascular problems
* Respiratory illness within 4 weeks of Visit 1
* Allergen-induced asthma exacerbation within 4 weeks of Visit 1

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Wright Donnée non disponible Methacholine challenge performed using the Wright nebulizer
  • Inconnu
  • Bennett-Twin Donnée non disponible Methacholine challenge performed using the Bennett-Twin nebulizer
  • Inconnu
  • Aeroneb Solo Donnée non disponible Methacholine challenge performed using the Aeroneb Solo nebulizer
  • Inconnu
  • Wright
    État du recrutement
    unknown
    Bennett-Twin
    État du recrutement
    unknown
    Aeroneb Solo
    État du recrutement
    unknown
    Données à jour depuis : 23 octobre 2017

    Description de l'étude

    Résumé de l'étude

    The study will assess three different nebulizers for use in methacholine challenge testing in order to determine if the Aeroneb Solo would make a suitable replacement for the long-used and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will be compared to evaluate whether current guidelines for the methacholine challenge should be updated for superior standardization.

    Source : Importé depuis le centre

    Sixty asthmatics (20 at each testing site: University of Saskatchewan, McMaster University, Laval University) will be recruited to undergo this randomized, triple cross-over study. Three nebulizers will be tested, the Wright, the Bennett-Twin and the new Aeroneb Solo.

    Breakdown of study procedure: Participants will undergo three (potentially four) methacholine challenges, one with each nebulizer in randomized order. An additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months. The screening challenge will be performed with the standard nebulizer used at the given testing site (i.e. the Wright or the Bennett-Twin).

    The methacholine challenges performed with the Wright and Bennett-Twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The testing protocol used with the Aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min. Each challenge will be stopped when a participant's forced expiratory volume in 1 second (FEV1) drops at least 20%. This will allow for the determination of the participant's PC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will subsequently be converted to a PD20 (provocative dose) value. A minimum 24-hour washout period between challenges will be enforced.

    Source : Importé depuis le centre

    Sites

    Centres participants

      3 centres
    • ASTHMA RESEARCH LAB - UNIVERSITY OF SASKATCHEWAN

      Saskatoon

      SASKATCHEWAN, CANADA

      Recrutement local
      État du recrutement: FERMÉ
    • LAVAL UNIVERSITY

      Québec

      QUEBEC, CANADA

      Recrutement local
      État du recrutement: FERMÉ
    • MCMASTER UNIVERSITY

      Hamilton

      ONTARIO, CANADA

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 23 octobre 2017
    Données à jour depuis : 26 juin
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT02822859