Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
9 aprile 2020 aggiornato da: 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.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
197
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ruse, Bulgaria, 7000
- Vectura Clinical Trial Site 08006
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Sofia, Bulgaria, 1000
- Vectura Clinical Trial Site 08005
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Sofia, Bulgaria, 1431
- Vectura Clinical Trial Site 08001
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Sofia, Bulgaria, 1431
- Vectura Clinical Trial Site 08003
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Sofia, Bulgaria, 1431
- Vectura Clinical Trial Site 08007
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Sofia, Bulgaria, 1606
- Vectura Clinical Trial Site 08004
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Stara Zagora, Bulgaria, 6000
- Vectura Clinical Trial Site 08002
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Varna, Bulgaria, 9000
- Vectura Clinical Trial Site 08008
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Berlin, Germania, 10717
- Vectura Clinical Trial Site 03006
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Berlin, Germania, 12203
- Vectura Clinical Trial Site 03009
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Bonn, Germania, 53119
- Vectura Clinical Trial Site 03004
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Donaustauf, Germania, 93093
- Vectura Clinical Trial Site 03008
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Dortmund, Germania, 44263
- Vectura Clinical Trial Site 03003
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Geesthacht, Germania, 21502
- Vectura Clinical Trial Site 03007
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Hamburg, Germania, 22767
- Vectura Clinical Trial Site 03001
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Heidelberg, Germania, 69126
- Vectura Clinical Trial Site 03005
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Rudersdorf, Germania, 15562
- Vectura Clinical Trial Site 03002
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Bialystok, Polonia, 15-003
- Vectura Clinical Trial Site 05008
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Bialystok, Polonia, 15-276
- Vectura Clinical Trial Site 05002
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Bialystok, Polonia, 15-430
- Vectura Clinical Trial Site 05010
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Krakow, Polonia, 31-024
- Vectura Clinical Trial Site 05011
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Lodz, Polonia, 90-153
- Vectura Clinical Trial Site 05001
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Lodz, Polonia, 90-153
- Vectura Clinical Trial Site 05006
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Lublin, Polonia, 20-552
- Vectura Clinical Trial Site 05005
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Tarnow, Polonia, 33-100
- Vectura Clinical Trial Site 05007
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Warszawa, Polonia, 02-097
- Vectura Clinical Trial Site 05003
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Wroclaw, Polonia, 51-162
- Vectura Clinical Trial Site 05009
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Zawadzkie, Polonia, 47-120
- Vectura Clinical Trial Site 05004
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Birmingham, Regno Unito, B9 5SS
- Vectura Clinical Trial site 02002
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Manchester, Regno Unito, M23 9LT
- Vectura Clinical Trial Site 02004
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Newcastle, Regno Unito, NE7 7DN
- Vectura Clinical Trial Site 02001
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Nottingham, Regno Unito, NG5 1PB
- Vectura Clinical Trial Site 02005
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Hull
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Cottingham, Hull, Regno Unito, HU16 5JQ
- Vectura Clinical Trial Site 02003
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Brasov, Romania, 500086
- Vectura Clinical Trial Site 07001
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Bucuresti, Romania, 010457
- Vectura Clinical Trial Site 07008
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Bucuresti, Romania, 020671
- Vectura Clinical Trial Site 07005
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Bucuresti, Romania, 030303
- Vectura Clinical Trial Site 07013
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Bucuresti, Romania, 050554
- Vectura Clinical Trial Site 07003
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Cluj-Napoca, Romania, 400371
- Vectura Clinical Trial Site 07006
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Cluj-Napoca, Romania, 400371
- Vectura Clinical Trial Site 07007
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Cluj-Napoca, Romania, 400371
- Vectura Clinical Trial Site 07009
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Cod, Romania, 700115
- Vectura Clinical Trial Site 07010
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Craiova, Romania, 200515
- Vectura Clinical Trial Site 07014
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Iasi, Romania, 700376
- Vectura Clinical Trial Site 07002
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Marghita, Romania, 415300
- Vectura Clinical Trial Site 07004
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Targu Mures, Romania, 540543
- Vectura Clinical Trial Site 07012
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Timis, Romania, 300310
- Vectura Clinicl Trial Site 07011
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California
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Los Angeles, California, Stati Uniti, 90025
- Vectura Clinical Trial Site 01001
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Colorado
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Denver, Colorado, Stati Uniti, 80206
- Vectura Clinial Trial Site 01005
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Florida
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Celebration, Florida, Stati Uniti, 34747
- Vectura Clinical Trial Site 01006
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Hialeah, Florida, Stati Uniti, 33018
- Vectura Clinical Trial Site 01015
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Miami Lakes, Florida, Stati Uniti, 33016
- Vectura Clinical Trial Site 01012
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Orlando, Florida, Stati Uniti, 32806
- Vectura Clinical Trial Site 01014
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Tampa, Florida, Stati Uniti, 33613
- Vectura Clinical Trial Site 01003
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110-1093
- Vectura Clinical Trial Site 01011
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New Jersey
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Jersey City, New Jersey, Stati Uniti, 07306
- Vectura Clinical Trial Site 01013
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New York
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Bronx, New York, Stati Uniti, 10461
- Vectura Clinical Trial Site 01004
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Texas
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El Paso, Texas, Stati Uniti, 79925
- Vectura Clinical Trial Site 01007
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AR Crimea, Ucraina, 97403
- Vectura Clinical Trial Site 06013
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Donetsk, Ucraina, 83099
- Vectura Clinical Trial Site 06009
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Ivano-Frankivsk, Ucraina, 76018
- Vectura Clinical Trial Site 06012
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Kharkiv, Ucraina, 61002
- Vectura Clinical Trial Site 06010
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Kharkiv, Ucraina, 61035
- Vectura Clinical Trial Site 06001
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Kharkiv, Ucraina, 61106
- Vectura Clinical Trial Site 06004
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Kyiv, Ucraina, 02232
- Vectura Clinical Trial Site 06006
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Kyiv, Ucraina, 03680
- Vectura Clinical Trial Site 06002
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Kyiv, Ucraina, 3680
- Vectura Clinical Trial Site 06015
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Kyviv, Ucraina, 04050
- Vectura Clinical Trial Site 06003
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Mykolaiv, Ucraina, 54003
- Vectura Clinical Trial Site 06008
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Vinnitsa, Ucraina, 21029
- Vectura Clinical Trial Site 06011
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Zaporizhzhia, Ucraina, 69600
- Vectura Clinical Trial Site 06007
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Zaporizhzhya, Ucraina, 69118
- Vectura Clinical Trial Site 06014
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Budapest, Ungheria, 1121
- Vectura Clinical Trial Site 04001
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Budapest, Ungheria, 1125
- Vectura Clinical Trial Site 04004
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Debrecen, Ungheria, 4032
- Vectura Clinical Trial Site 04003
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Rakoczi, Ungheria, 125 127
- Vectura Clinical Trial Site 04002
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Rakoczi, Ungheria, 7100
- Vectura Clinical Trial Site 04005
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 12 anni a 65 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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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Comparatore attivo: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 16 weeks
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16 weeks
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Assessment of Acceptability of the Device
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2012
Completamento primario (Effettivo)
1 ottobre 2013
Completamento dello studio (Effettivo)
1 ottobre 2013
Date di iscrizione allo studio
Primo inviato
30 ottobre 2012
Primo inviato che soddisfa i criteri di controllo qualità
30 ottobre 2012
Primo Inserito (Stima)
1 novembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 aprile 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 aprile 2020
Ultimo verificato
1 aprile 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VR506/2/004
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su VR506
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Vectura LimitedCompletatoAsmaStati Uniti, Filippine, Polonia, Romania, Ucraina