Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
9. april 2020 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
197
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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California
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Los Angeles, California, Forente stater, 90025
- Vectura Clinical Trial Site 01001
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Colorado
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Denver, Colorado, Forente stater, 80206
- Vectura Clinial Trial Site 01005
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Florida
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Celebration, Florida, Forente stater, 34747
- Vectura Clinical Trial Site 01006
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Hialeah, Florida, Forente stater, 33018
- Vectura Clinical Trial Site 01015
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Miami Lakes, Florida, Forente stater, 33016
- Vectura Clinical Trial Site 01012
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Orlando, Florida, Forente stater, 32806
- Vectura Clinical Trial Site 01014
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Tampa, Florida, Forente stater, 33613
- Vectura Clinical Trial Site 01003
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Missouri
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Saint Louis, Missouri, Forente stater, 63110-1093
- Vectura Clinical Trial Site 01011
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New Jersey
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Jersey City, New Jersey, Forente stater, 07306
- Vectura Clinical Trial Site 01013
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New York
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Bronx, New York, Forente stater, 10461
- Vectura Clinical Trial Site 01004
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Texas
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El Paso, Texas, Forente stater, 79925
- Vectura Clinical Trial Site 01007
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Bialystok, Polen, 15-003
- Vectura Clinical Trial Site 05008
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Bialystok, Polen, 15-276
- Vectura Clinical Trial Site 05002
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Bialystok, Polen, 15-430
- Vectura Clinical Trial Site 05010
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Krakow, Polen, 31-024
- Vectura Clinical Trial Site 05011
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Lodz, Polen, 90-153
- Vectura Clinical Trial Site 05001
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Lodz, Polen, 90-153
- Vectura Clinical Trial Site 05006
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Lublin, Polen, 20-552
- Vectura Clinical Trial Site 05005
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Tarnow, Polen, 33-100
- Vectura Clinical Trial Site 05007
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Warszawa, Polen, 02-097
- Vectura Clinical Trial Site 05003
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Wroclaw, Polen, 51-162
- Vectura Clinical Trial Site 05009
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Zawadzkie, Polen, 47-120
- Vectura Clinical Trial Site 05004
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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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Birmingham, Storbritannia, B9 5SS
- Vectura Clinical Trial site 02002
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Manchester, Storbritannia, M23 9LT
- Vectura Clinical Trial Site 02004
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Newcastle, Storbritannia, NE7 7DN
- Vectura Clinical Trial Site 02001
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Nottingham, Storbritannia, NG5 1PB
- Vectura Clinical Trial Site 02005
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Hull
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Cottingham, Hull, Storbritannia, HU16 5JQ
- Vectura Clinical Trial Site 02003
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Berlin, Tyskland, 10717
- Vectura Clinical Trial Site 03006
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Berlin, Tyskland, 12203
- Vectura Clinical Trial Site 03009
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Bonn, Tyskland, 53119
- Vectura Clinical Trial Site 03004
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Donaustauf, Tyskland, 93093
- Vectura Clinical Trial Site 03008
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Dortmund, Tyskland, 44263
- Vectura Clinical Trial Site 03003
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Geesthacht, Tyskland, 21502
- Vectura Clinical Trial Site 03007
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Hamburg, Tyskland, 22767
- Vectura Clinical Trial Site 03001
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Heidelberg, Tyskland, 69126
- Vectura Clinical Trial Site 03005
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Rudersdorf, Tyskland, 15562
- Vectura Clinical Trial Site 03002
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AR Crimea, Ukraina, 97403
- Vectura Clinical Trial Site 06013
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Donetsk, Ukraina, 83099
- Vectura Clinical Trial Site 06009
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Ivano-Frankivsk, Ukraina, 76018
- Vectura Clinical Trial Site 06012
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Kharkiv, Ukraina, 61002
- Vectura Clinical Trial Site 06010
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Kharkiv, Ukraina, 61035
- Vectura Clinical Trial Site 06001
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Kharkiv, Ukraina, 61106
- Vectura Clinical Trial Site 06004
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Kyiv, Ukraina, 02232
- Vectura Clinical Trial Site 06006
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Kyiv, Ukraina, 03680
- Vectura Clinical Trial Site 06002
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Kyiv, Ukraina, 3680
- Vectura Clinical Trial Site 06015
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Kyviv, Ukraina, 04050
- Vectura Clinical Trial Site 06003
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Mykolaiv, Ukraina, 54003
- Vectura Clinical Trial Site 06008
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Vinnitsa, Ukraina, 21029
- Vectura Clinical Trial Site 06011
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Zaporizhzhia, Ukraina, 69600
- Vectura Clinical Trial Site 06007
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Zaporizhzhya, Ukraina, 69118
- Vectura Clinical Trial Site 06014
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Budapest, Ungarn, 1121
- Vectura Clinical Trial Site 04001
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Budapest, Ungarn, 1125
- Vectura Clinical Trial Site 04004
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Debrecen, Ungarn, 4032
- Vectura Clinical Trial Site 04003
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Rakoczi, Ungarn, 125 127
- Vectura Clinical Trial Site 04002
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Rakoczi, Ungarn, 7100
- Vectura Clinical Trial Site 04005
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år til 65 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Aktiv komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 16 weeks
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16 weeks
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Assessment of Acceptability of the Device
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. oktober 2013
Studiet fullført (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først innsendt
30. oktober 2012
Først innsendt som oppfylte QC-kriteriene
30. oktober 2012
Først lagt ut (Anslag)
1. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. april 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VR506/2/004
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .