Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
9. april 2020 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
197
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Ruse, Bulgarien, 7000
- Vectura Clinical Trial Site 08006
-
Sofia, Bulgarien, 1000
- Vectura Clinical Trial Site 08005
-
Sofia, Bulgarien, 1431
- Vectura Clinical Trial Site 08001
-
Sofia, Bulgarien, 1431
- Vectura Clinical Trial Site 08003
-
Sofia, Bulgarien, 1431
- Vectura Clinical Trial Site 08007
-
Sofia, Bulgarien, 1606
- Vectura Clinical Trial Site 08004
-
Stara Zagora, Bulgarien, 6000
- Vectura Clinical Trial Site 08002
-
Varna, Bulgarien, 9000
- Vectura Clinical Trial Site 08008
-
-
-
-
-
Birmingham, Det Forenede Kongerige, B9 5SS
- Vectura Clinical Trial site 02002
-
Manchester, Det Forenede Kongerige, M23 9LT
- Vectura Clinical Trial Site 02004
-
Newcastle, Det Forenede Kongerige, NE7 7DN
- Vectura Clinical Trial Site 02001
-
Nottingham, Det Forenede Kongerige, NG5 1PB
- Vectura Clinical Trial Site 02005
-
-
Hull
-
Cottingham, Hull, Det Forenede Kongerige, HU16 5JQ
- Vectura Clinical Trial Site 02003
-
-
-
-
California
-
Los Angeles, California, Forenede Stater, 90025
- Vectura Clinical Trial Site 01001
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80206
- Vectura Clinial Trial Site 01005
-
-
Florida
-
Celebration, Florida, Forenede Stater, 34747
- Vectura Clinical Trial Site 01006
-
Hialeah, Florida, Forenede Stater, 33018
- Vectura Clinical Trial Site 01015
-
Miami Lakes, Florida, Forenede Stater, 33016
- Vectura Clinical Trial Site 01012
-
Orlando, Florida, Forenede Stater, 32806
- Vectura Clinical Trial Site 01014
-
Tampa, Florida, Forenede Stater, 33613
- Vectura Clinical Trial Site 01003
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110-1093
- Vectura Clinical Trial Site 01011
-
-
New Jersey
-
Jersey City, New Jersey, Forenede Stater, 07306
- Vectura Clinical Trial Site 01013
-
-
New York
-
Bronx, New York, Forenede Stater, 10461
- Vectura Clinical Trial Site 01004
-
-
Texas
-
El Paso, Texas, Forenede Stater, 79925
- Vectura Clinical Trial Site 01007
-
-
-
-
-
Bialystok, Polen, 15-003
- Vectura Clinical Trial Site 05008
-
Bialystok, Polen, 15-276
- Vectura Clinical Trial Site 05002
-
Bialystok, Polen, 15-430
- Vectura Clinical Trial Site 05010
-
Krakow, Polen, 31-024
- Vectura Clinical Trial Site 05011
-
Lodz, Polen, 90-153
- Vectura Clinical Trial Site 05001
-
Lodz, Polen, 90-153
- Vectura Clinical Trial Site 05006
-
Lublin, Polen, 20-552
- Vectura Clinical Trial Site 05005
-
Tarnow, Polen, 33-100
- Vectura Clinical Trial Site 05007
-
Warszawa, Polen, 02-097
- Vectura Clinical Trial Site 05003
-
Wroclaw, Polen, 51-162
- Vectura Clinical Trial Site 05009
-
Zawadzkie, Polen, 47-120
- Vectura Clinical Trial Site 05004
-
-
-
-
-
Brasov, Rumænien, 500086
- Vectura Clinical Trial Site 07001
-
Bucuresti, Rumænien, 010457
- Vectura Clinical Trial Site 07008
-
Bucuresti, Rumænien, 020671
- Vectura Clinical Trial Site 07005
-
Bucuresti, Rumænien, 030303
- Vectura Clinical Trial Site 07013
-
Bucuresti, Rumænien, 050554
- Vectura Clinical Trial Site 07003
-
Cluj-Napoca, Rumænien, 400371
- Vectura Clinical Trial Site 07006
-
Cluj-Napoca, Rumænien, 400371
- Vectura Clinical Trial Site 07007
-
Cluj-Napoca, Rumænien, 400371
- Vectura Clinical Trial Site 07009
-
Cod, Rumænien, 700115
- Vectura Clinical Trial Site 07010
-
Craiova, Rumænien, 200515
- Vectura Clinical Trial Site 07014
-
Iasi, Rumænien, 700376
- Vectura Clinical Trial Site 07002
-
Marghita, Rumænien, 415300
- Vectura Clinical Trial Site 07004
-
Targu Mures, Rumænien, 540543
- Vectura Clinical Trial Site 07012
-
Timis, Rumænien, 300310
- Vectura Clinicl Trial Site 07011
-
-
-
-
-
Berlin, Tyskland, 10717
- Vectura Clinical Trial Site 03006
-
Berlin, Tyskland, 12203
- Vectura Clinical Trial Site 03009
-
Bonn, Tyskland, 53119
- Vectura Clinical Trial Site 03004
-
Donaustauf, Tyskland, 93093
- Vectura Clinical Trial Site 03008
-
Dortmund, Tyskland, 44263
- Vectura Clinical Trial Site 03003
-
Geesthacht, Tyskland, 21502
- Vectura Clinical Trial Site 03007
-
Hamburg, Tyskland, 22767
- Vectura Clinical Trial Site 03001
-
Heidelberg, Tyskland, 69126
- Vectura Clinical Trial Site 03005
-
Rudersdorf, Tyskland, 15562
- Vectura Clinical Trial Site 03002
-
-
-
-
-
AR Crimea, Ukraine, 97403
- Vectura Clinical Trial Site 06013
-
Donetsk, Ukraine, 83099
- Vectura Clinical Trial Site 06009
-
Ivano-Frankivsk, Ukraine, 76018
- Vectura Clinical Trial Site 06012
-
Kharkiv, Ukraine, 61002
- Vectura Clinical Trial Site 06010
-
Kharkiv, Ukraine, 61035
- Vectura Clinical Trial Site 06001
-
Kharkiv, Ukraine, 61106
- Vectura Clinical Trial Site 06004
-
Kyiv, Ukraine, 02232
- Vectura Clinical Trial Site 06006
-
Kyiv, Ukraine, 03680
- Vectura Clinical Trial Site 06002
-
Kyiv, Ukraine, 3680
- Vectura Clinical Trial Site 06015
-
Kyviv, Ukraine, 04050
- Vectura Clinical Trial Site 06003
-
Mykolaiv, Ukraine, 54003
- Vectura Clinical Trial Site 06008
-
Vinnitsa, Ukraine, 21029
- Vectura Clinical Trial Site 06011
-
Zaporizhzhia, Ukraine, 69600
- Vectura Clinical Trial Site 06007
-
Zaporizhzhya, Ukraine, 69118
- Vectura Clinical Trial Site 06014
-
-
-
-
-
Budapest, Ungarn, 1121
- Vectura Clinical Trial Site 04001
-
Budapest, Ungarn, 1125
- Vectura Clinical Trial Site 04004
-
Debrecen, Ungarn, 4032
- Vectura Clinical Trial Site 04003
-
Rakoczi, Ungarn, 125 127
- Vectura Clinical Trial Site 04002
-
Rakoczi, Ungarn, 7100
- Vectura Clinical Trial Site 04005
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
|
VR506 inhalation powder delivered via a new dry powder inhaler device
|
|
Aktiv komparator: Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
|
VR506 inhalation powder delivered via a new dry powder inhaler device
|
|
Aktiv komparator: Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
|
VR506 inhalation powder delivered via a new dry powder inhaler device
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Tidsramme: 16 weeks
|
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
Baseline and 16 weeks
|
|
|
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
|
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).
|
Baseline and 16 weeks
|
|
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
|
Baseline and 16 weeks
|
|
|
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
|
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).
|
Baseline and 16 weeks
|
|
Number of Participants With Withdrawals Due to Worsening of Asthma
Tidsramme: 16 weeks
|
16 weeks
|
|
|
Assessment of Acceptability of the Device
Tidsramme: 16 weeks
|
Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
|
16 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
30. oktober 2012
Først indsendt, der opfyldte QC-kriterier
30. oktober 2012
Først opslået (Skøn)
1. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. april 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VR506/2/004
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med VR506
-
Vectura LimitedAfsluttetAstmaForenede Stater, Filippinerne, Polen, Rumænien, Ukraine