- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01197482
Inhaled Steroids and Control of Severe Asthma (INHALE)
Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)
Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)
Objectives: To explore if inhalative fluticasone application by means of the AKITA technology would result in a better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional MDI.
Study design: open label, cross-over (one AKITA, one MDI arm)
Patients: 20 Patients with severe persistent asthma
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Giessen, Allemagne, 35392
- Justus-Liebig-University Giessen
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Greifenstein, Allemagne
- Lungenfachklinik Waldhof Elgershausen
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Marburg, Allemagne
- Philipps-Universität Marburg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Severe persistent asthma bronchiale with diagnosis according to the criteria of the Global Initiative for Asthma (GINA) executive summary
- Treatment with at least inhaled corticosteroids (ICS) and long acting b agonists (LABA)
- Evidence of inflammatory triggered form of asthma with at least one of the following:
- sensitization to typical aerogenous allergens
- increased Serum IgE levels
- Eosinophilia in peripheral blood
- Proven Eosinophilia in sputum differential (> 3%) in the previous 2 years
- at least 2 exacerbations of asthma within the previous 24 months leading to unscheduled presentation at a health care provider and/or systemic corticosteroid
- Signed informed consent
- Requirements of the local ethics committee are met
Exclusion Criteria:
- Acute exacerbation of asthma within the last 6 weeks Rtot > 350% predicted capillary pO2 < 60mmHG, pCo2 > 50mmHG near fatal asthma or anaphylaxis in history
- Age ≤ 18 and > 80 years
- Active smoking or > 15 pack-years former smoking
- Oral steroid treatment with a prednisolon-equivalent dose exceeding 10 mg per day
- Pregnancy, nursing females
- Female without use of effective contraceptive method
- Treatment with investigational drugs over the past 30 days or during the course of the trial
- Severe and uncontrolled gastroesophageal reflux disease
- Ongoing psychiatric disorder
- Treatment with systemic corticosteroids for any reason other than asthma
- Other active lung diseases
- Medical history of other uncontrolled diseases 3 months prior randomization (e.g. infections, coronary heart diseases and metabolic diseases)
- Any history of malignancy requiring ongoing treatment and/or limiting life-expectancy
- Clinically significant abnormalities in electrocardiogram (ECG) or laboratory exams
- Asthma related to non-steroidal anti-inflammatory drug (NSAID)
- Insulin dependent diabetes mellitus
- Cataract
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Asthma control
Délai: 38 weeks
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Changes in asthma control, measured by Juniper Asthma Control Questionnaire during the 16 week treatment period in AKITA versus MDI based steroid application.
Physician will assess level of asthma control in accordance with criteria from Gaining Optimal Asthma Control (GOAL) study.
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38 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Standardized asthma related quality of life questionnaire (AQLQs)
Délai: 38 weeks
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AQLQs will be completed at screening, randomization, crossover and at end of study
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38 weeks
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Steroid, fluticasone and reliever medication use
Délai: 38 weeks
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doses of systemic steroids and fluticasone dosage will be assessed and documented.
Frequency of use of reliever medication will be summed from patient's diary and documented.
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38 weeks
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Lung function
Délai: 38 weeks
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Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography.
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38 weeks
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Diffusing capacity for carbon monoxide
Délai: 38 weeks
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Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.
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38 weeks
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Capillary blood gas analysis
Délai: 38 weeks
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Capillary blood gas analysis will be obtained from the arterialized ear lobe.
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38 weeks
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Measurement of Fractional Concentration of Nitric Oxide in Exhaled Air (feNO)
Délai: 38 weeks
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feNO will be assessed at each visit.
Measurements will be performed following the recommendations of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
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38 weeks
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Cell differential in induced sputa
Délai: 1 day
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Induced sputum will be obtained at screening if not done within the previous 2 years.
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1 day
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Adrenal function
Délai: 38 weeks
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Determination of the fraction of urinary cortisol has been used for screening of adrenal hypo- or hyperfunction and showed to be as effective as 24 hour urinary free cortisol excretion.
Urine samples will be obtained at baseline, randomization, crossover and end of study.Values will be recorded.
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38 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Andreas Guenther, MD, University of Gießen
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AZ 109/09
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