Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
27 mai 2014 mis à jour par: Boehringer Ingelheim
Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL.
Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Heerlen, Pays-Bas
- 1222.3.1 Atrium medisch centrum
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease
- Smoking history of more than 10-pack years
Exclusion criteria:
- History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
- Marked baseline prolongation of QT/QTc interval
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: olodaterol 2 mcg
solution for inhalation
|
solution for inhalation
|
|
Expérimental: olodaterol 5 mcg
solution for inhalation
|
solution for inhalation
|
|
Expérimental: olodaterol 10 mcg
solution for inhalation
|
solution for inhalation
|
|
Expérimental: olodaterol 20 mcg
solution for inhalation
|
solution for inhalation
|
|
Expérimental: olodaterol 40 mcg
solution for inhalation
|
solution for inhalation
|
|
Comparateur placebo: placebo
solution for inhalation
|
solution for inhalation
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
Délai: 24 hours post-dosing
|
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment.
Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects.
Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
|
24 hours post-dosing
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
FEV1 AUC 0 - 3 Hours
Délai: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
|
-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
|
|
FEV1 AUC 0 - 12 Hours
Délai: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
|
|
FEV1 AUC 0 - 24 Hours
Délai: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
|
-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
|
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FEV1 AUC 12 - 24 Hours
Délai: 12h, 14h, 22h, 23h and 24h post-dosing
|
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
|
12h, 14h, 22h, 23h and 24h post-dosing
|
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Peak FEV1 From 0 to 3 Hours
Délai: 0 to 3 hours post-dosing
|
Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
|
0 to 3 hours post-dosing
|
|
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
Délai: 0 to 3 hours post-dosing
|
Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
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0 to 3 hours post-dosing
|
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Time to Peak Bronchodilator Response
Délai: 0 to 3 hours post-dosing
|
A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
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0 to 3 hours post-dosing
|
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Time to Onset of Response
Délai: 0 to 3 hours post-dosing
|
Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation).
If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
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0 to 3 hours post-dosing
|
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Number of Patients Requiring Rescue Medication on a Test-day
Délai: Visits 1,2,4,5,6
|
Number of Patients Requiring Rescue Medication on a Test-day.
Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication.
Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
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Visits 1,2,4,5,6
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Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Délai: 2 weeks
|
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG.
New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
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2 weeks
|
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Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Délai: Baseline and Visit 6
|
Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
|
Baseline and Visit 6
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Collaborateurs et enquêteurs
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Parrainer
Publications et liens utiles
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Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2005
Achèvement primaire (Réel)
1 novembre 2006
Achèvement de l'étude (Réel)
1 novembre 2006
Dates d'inscription aux études
Première soumission
8 mars 2013
Première soumission répondant aux critères de contrôle qualité
8 mars 2013
Première publication (Estimation)
12 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 juin 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1222.3
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