Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
9 avril 2020 mis à jour par: Vectura Limited
A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e.
Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
197
Phase
- Phase 2
- Phase 3
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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Berlin, Allemagne, 10717
- Vectura Clinical Trial Site 03006
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Berlin, Allemagne, 12203
- Vectura Clinical Trial Site 03009
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Bonn, Allemagne, 53119
- Vectura Clinical Trial Site 03004
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Donaustauf, Allemagne, 93093
- Vectura Clinical Trial Site 03008
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Dortmund, Allemagne, 44263
- Vectura Clinical Trial Site 03003
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Geesthacht, Allemagne, 21502
- Vectura Clinical Trial Site 03007
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Hamburg, Allemagne, 22767
- Vectura Clinical Trial Site 03001
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Heidelberg, Allemagne, 69126
- Vectura Clinical Trial Site 03005
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Rudersdorf, Allemagne, 15562
- Vectura Clinical Trial Site 03002
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Ruse, Bulgarie, 7000
- Vectura Clinical Trial Site 08006
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Sofia, Bulgarie, 1000
- Vectura Clinical Trial Site 08005
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Sofia, Bulgarie, 1431
- Vectura Clinical Trial Site 08001
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Sofia, Bulgarie, 1431
- Vectura Clinical Trial Site 08003
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Sofia, Bulgarie, 1431
- Vectura Clinical Trial Site 08007
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Sofia, Bulgarie, 1606
- Vectura Clinical Trial Site 08004
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Stara Zagora, Bulgarie, 6000
- Vectura Clinical Trial Site 08002
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Varna, Bulgarie, 9000
- Vectura Clinical Trial Site 08008
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Budapest, Hongrie, 1121
- Vectura Clinical Trial Site 04001
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Budapest, Hongrie, 1125
- Vectura Clinical Trial Site 04004
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Debrecen, Hongrie, 4032
- Vectura Clinical Trial Site 04003
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Rakoczi, Hongrie, 125 127
- Vectura Clinical Trial Site 04002
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Rakoczi, Hongrie, 7100
- Vectura Clinical Trial Site 04005
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Bialystok, Pologne, 15-003
- Vectura Clinical Trial Site 05008
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Bialystok, Pologne, 15-276
- Vectura Clinical Trial Site 05002
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Bialystok, Pologne, 15-430
- Vectura Clinical Trial Site 05010
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Krakow, Pologne, 31-024
- Vectura Clinical Trial Site 05011
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Lodz, Pologne, 90-153
- Vectura Clinical Trial Site 05001
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Lodz, Pologne, 90-153
- Vectura Clinical Trial Site 05006
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Lublin, Pologne, 20-552
- Vectura Clinical Trial Site 05005
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Tarnow, Pologne, 33-100
- Vectura Clinical Trial Site 05007
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Warszawa, Pologne, 02-097
- Vectura Clinical Trial Site 05003
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Wroclaw, Pologne, 51-162
- Vectura Clinical Trial Site 05009
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Zawadzkie, Pologne, 47-120
- Vectura Clinical Trial Site 05004
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Brasov, Roumanie, 500086
- Vectura Clinical Trial Site 07001
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Bucuresti, Roumanie, 010457
- Vectura Clinical Trial Site 07008
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Bucuresti, Roumanie, 020671
- Vectura Clinical Trial Site 07005
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Bucuresti, Roumanie, 030303
- Vectura Clinical Trial Site 07013
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Bucuresti, Roumanie, 050554
- Vectura Clinical Trial Site 07003
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Cluj-Napoca, Roumanie, 400371
- Vectura Clinical Trial Site 07006
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Cluj-Napoca, Roumanie, 400371
- Vectura Clinical Trial Site 07007
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Cluj-Napoca, Roumanie, 400371
- Vectura Clinical Trial Site 07009
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Cod, Roumanie, 700115
- Vectura Clinical Trial Site 07010
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Craiova, Roumanie, 200515
- Vectura Clinical Trial Site 07014
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Iasi, Roumanie, 700376
- Vectura Clinical Trial Site 07002
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Marghita, Roumanie, 415300
- Vectura Clinical Trial Site 07004
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Targu Mures, Roumanie, 540543
- Vectura Clinical Trial Site 07012
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Timis, Roumanie, 300310
- Vectura Clinicl Trial Site 07011
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Birmingham, Royaume-Uni, B9 5SS
- Vectura Clinical Trial site 02002
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Manchester, Royaume-Uni, M23 9LT
- Vectura Clinical Trial Site 02004
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Newcastle, Royaume-Uni, NE7 7DN
- Vectura Clinical Trial Site 02001
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Nottingham, Royaume-Uni, NG5 1PB
- Vectura Clinical Trial Site 02005
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Hull
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Cottingham, Hull, Royaume-Uni, HU16 5JQ
- Vectura Clinical Trial Site 02003
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AR Crimea, Ukraine, 97403
- Vectura Clinical Trial Site 06013
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Donetsk, Ukraine, 83099
- Vectura Clinical Trial Site 06009
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Ivano-Frankivsk, Ukraine, 76018
- Vectura Clinical Trial Site 06012
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Kharkiv, Ukraine, 61002
- Vectura Clinical Trial Site 06010
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Kharkiv, Ukraine, 61035
- Vectura Clinical Trial Site 06001
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Kharkiv, Ukraine, 61106
- Vectura Clinical Trial Site 06004
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Kyiv, Ukraine, 02232
- Vectura Clinical Trial Site 06006
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Kyiv, Ukraine, 03680
- Vectura Clinical Trial Site 06002
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Kyiv, Ukraine, 3680
- Vectura Clinical Trial Site 06015
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Kyviv, Ukraine, 04050
- Vectura Clinical Trial Site 06003
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Mykolaiv, Ukraine, 54003
- Vectura Clinical Trial Site 06008
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Vinnitsa, Ukraine, 21029
- Vectura Clinical Trial Site 06011
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Zaporizhzhia, Ukraine, 69600
- Vectura Clinical Trial Site 06007
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Zaporizhzhya, Ukraine, 69118
- Vectura Clinical Trial Site 06014
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California
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Los Angeles, California, États-Unis, 90025
- Vectura Clinical Trial Site 01001
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Colorado
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Denver, Colorado, États-Unis, 80206
- Vectura Clinial Trial Site 01005
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Florida
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Celebration, Florida, États-Unis, 34747
- Vectura Clinical Trial Site 01006
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Hialeah, Florida, États-Unis, 33018
- Vectura Clinical Trial Site 01015
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Miami Lakes, Florida, États-Unis, 33016
- Vectura Clinical Trial Site 01012
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Orlando, Florida, États-Unis, 32806
- Vectura Clinical Trial Site 01014
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Tampa, Florida, États-Unis, 33613
- Vectura Clinical Trial Site 01003
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Missouri
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Saint Louis, Missouri, États-Unis, 63110-1093
- Vectura Clinical Trial Site 01011
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New Jersey
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Jersey City, New Jersey, États-Unis, 07306
- Vectura Clinical Trial Site 01013
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New York
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Bronx, New York, États-Unis, 10461
- Vectura Clinical Trial Site 01004
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Texas
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El Paso, Texas, États-Unis, 79925
- Vectura Clinical Trial Site 01007
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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
12 ans à 65 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion:
- Written informed consent
- Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive)
- Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA
- Stable OCS dose for ≥7 days before Screening Visit & during Screening Period.
- At least 80% compliant w/regular asthma medication per investigator at end of Screening Period
- Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator
- Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist
- Ability to use eDiary correctly, assessed by investigator at end of Screening Period
- Ability to comply w/study procedures, including blood sampling
- Ability to perform technically satisfactory pulmonary function tests
- Available to complete all study visits before 12 noon
- BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults
- Oral PIF ≥40 L/min, using an appropriate device set to match resistance of inhaler
- Good health, except for presence of asthma, per medical history/physical examination
- Negative drug/alcohol/urine cotinine screen. Subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol & opiates (unless given as prescription medicine)
- Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. <20 cigarettes per day for 10 years or <40 cigarettes per day for 5 years) & stopped smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted throughout study
- Female subjects of child-bearing potential must be using medically acceptable forms of contraception [abstinence, hormonal (oral/implant/transdermal/injection), in use for ≥3 consecutive months before first dose of study medication, double barrier (condom w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (≥6 months since vasectomy)].
Exclusion:
- Regular use (≥3 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic conjunctivitis, within 28 days of Screening Visit
- Subjects who have/who have had, an upper/lower respiratory tract infection within 28 days of Screening Visit
- Subjects w/"brittle asthma
- Subjects w/asthma that required admission to an ICU and/or ventilation within previous 12 months
- Subjects whose comorbidities, per investigator's opinion, are major contributors to their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness, vocal cord dysfunction, gastro-oesophageal reflux)
- Previously/currently diagnosed as having Churg-Strauss syndrome
- Previously/currently diagnosed as having pulmonary eosinophilia
- History of lung cancer
- Subjects w/current diagnosis of HIV infection
- Active chronic hepatitis B or C infection
- Subjects who have clinically significant abnormality/finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
- Subjects with an abnormal ECG
- Persistent arterial hypotension, with average SBP readings of ≤95 mmHg
- Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average DBP readings of ≥100 mmHg
- Pregnant or lactating females
- Participation in another clinical study in 28 days prior to Screening Visit
- Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrectable hypokalaemia, or predisposition to low levels of serum potassium
- Current/history of drug/alcohol abuse/dependence per WHO criteria
- Inability to communicate well w/investigator
- Donation of ≥450 mL of blood/blood products within previous 3 months prior to screening
- History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe allergy to milk proteins
- Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or during Screening Visit
- History of medically diagnosed chronic respiratory diseases other than asthma (e.g. chronic obstructive pulmonary disease, ABPA in the absence of asthma)
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 parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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Comparateur actif: Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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Comparateur actif: Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
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VR506 inhalation powder delivered via a new dry powder inhaler device
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Délai: 16 weeks
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The mean asthma control prednisone/prednisolone dose at end of study (week 16)
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16 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
Délai: Baseline and 16 weeks
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
Délai: Baseline and 16 weeks
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Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)).
The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
Délai: Baseline and 16 weeks
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Baseline and 16 weeks
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Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score
Délai: Baseline and 16 weeks
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To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
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Baseline and 16 weeks
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Number of Participants With Withdrawals Due to Worsening of Asthma
Délai: 16 weeks
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16 weeks
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Assessment of Acceptability of the Device
Délai: 16 weeks
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Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
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16 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 octobre 2012
Achèvement primaire (Réel)
1 octobre 2013
Achèvement de l'étude (Réel)
1 octobre 2013
Dates d'inscription aux études
Première soumission
30 octobre 2012
Première soumission répondant aux critères de contrôle qualité
30 octobre 2012
Première publication (Estimation)
1 novembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 avril 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 avril 2020
Dernière vérification
1 avril 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VR506/2/004
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .