Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
NCT ID: NCT01720069
Last Updated: 2020-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
197 participants
INTERVENTIONAL
2012-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Interventions
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VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Eligibility Criteria
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Inclusion Criteria
* 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)
12 Years
65 Years
ALL
No
Sponsors
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Vectura Limited
INDUSTRY
Responsible Party
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Locations
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Vectura Clinical Trial Site 01001
Los Angeles, California, United States
Vectura Clinial Trial Site 01005
Denver, Colorado, United States
Vectura Clinical Trial Site 01006
Celebration, Florida, United States
Vectura Clinical Trial Site 01015
Hialeah, Florida, United States
Vectura Clinical Trial Site 01012
Miami Lakes, Florida, United States
Vectura Clinical Trial Site 01014
Orlando, Florida, United States
Vectura Clinical Trial Site 01003
Tampa, Florida, United States
Vectura Clinical Trial Site 01011
St Louis, Missouri, United States
Vectura Clinical Trial Site 01013
Jersey City, New Jersey, United States
Vectura Clinical Trial Site 01004
The Bronx, New York, United States
Vectura Clinical Trial Site 01007
El Paso, Texas, United States
Vectura Clinical Trial Site 08006
Rousse, , Bulgaria
Vectura Clinical Trial Site 08005
Sofia, , Bulgaria
Vectura Clinical Trial Site 08001
Sofia, , Bulgaria
Vectura Clinical Trial Site 08003
Sofia, , Bulgaria
Vectura Clinical Trial Site 08007
Sofia, , Bulgaria
Vectura Clinical Trial Site 08004
Sofia, , Bulgaria
Vectura Clinical Trial Site 08002
Stara Zagora, , Bulgaria
Vectura Clinical Trial Site 08008
Varna, , Bulgaria
Vectura Clinical Trial Site 03006
Berlin, , Germany
Vectura Clinical Trial Site 03009
Berlin, , Germany
Vectura Clinical Trial Site 03004
Bonn, , Germany
Vectura Clinical Trial Site 03008
Donaustauf, , Germany
Vectura Clinical Trial Site 03003
Dortmund, , Germany
Vectura Clinical Trial Site 03007
Geesthacht, , Germany
Vectura Clinical Trial Site 03001
Hamburg, , Germany
Vectura Clinical Trial Site 03005
Heidelberg, , Germany
Vectura Clinical Trial Site 03002
Rudersdorf, , Germany
Vectura Clinical Trial Site 04001
Budapest, , Hungary
Vectura Clinical Trial Site 04004
Budapest, , Hungary
Vectura Clinical Trial Site 04003
Debrecen, , Hungary
Vectura Clinical Trial Site 04002
Rakoczi, , Hungary
Vectura Clinical Trial Site 04005
Rakoczi, , Hungary
Vectura Clinical Trial Site 05008
Bialystok, , Poland
Vectura Clinical Trial Site 05002
Bialystok, , Poland
Vectura Clinical Trial Site 05010
Bialystok, , Poland
Vectura Clinical Trial Site 05011
Krakow, , Poland
Vectura Clinical Trial Site 05001
Lodz, , Poland
Vectura Clinical Trial Site 05006
Lodz, , Poland
Vectura Clinical Trial Site 05005
Lublin, , Poland
Vectura Clinical Trial Site 05007
Tarnów, , Poland
Vectura Clinical Trial Site 05003
Warsaw, , Poland
Vectura Clinical Trial Site 05009
Wroclaw, , Poland
Vectura Clinical Trial Site 05004
Zawadzkie, , Poland
Vectura Clinical Trial Site 07001
Brasov, , Romania
Vectura Clinical Trial Site 07008
Bucharest, , Romania
Vectura Clinical Trial Site 07005
Bucharest, , Romania
Vectura Clinical Trial Site 07013
Bucharest, , Romania
Vectura Clinical Trial Site 07003
Bucharest, , Romania
Vectura Clinical Trial Site 07006
Cluj-Napoca, , Romania
Vectura Clinical Trial Site 07007
Cluj-Napoca, , Romania
Vectura Clinical Trial Site 07009
Cluj-Napoca, , Romania
Vectura Clinical Trial Site 07014
Craiova, , Romania
Vectura Clinical Trial Site 07002
Iași, , Romania
Vectura Clinical Trial Site 07004
Marghita, , Romania
Vectura Clinical Trial Site 07010
Sadu, , Romania
Vectura Clinical Trial Site 07012
Târgu Mureş, , Romania
Vectura Clinicl Trial Site 07011
Timuș, , Romania
Vectura Clinical Trial Site 06013
AR Crimea, , Ukraine
Vectura Clinical Trial Site 06009
Donetsk, , Ukraine
Vectura Clinical Trial Site 06012
Ivano-Frankivsk, , Ukraine
Vectura Clinical Trial Site 06010
Kharkiv, , Ukraine
Vectura Clinical Trial Site 06001
Kharkiv, , Ukraine
Vectura Clinical Trial Site 06004
Kharkiv, , Ukraine
Vectura Clinical Trial Site 06006
Kyiv, , Ukraine
Vectura Clinical Trial Site 06002
Kyiv, , Ukraine
Vectura Clinical Trial Site 06015
Kyiv, , Ukraine
Vectura Clinical Trial Site 06003
Kyviv, , Ukraine
Vectura Clinical Trial Site 06008
Mykolaiv, , Ukraine
Vectura Clinical Trial Site 06011
Vinnitsa, , Ukraine
Vectura Clinical Trial Site 06007
Zaporizhzhia, , Ukraine
Vectura Clinical Trial Site 06014
Zaporizhzhya, , Ukraine
Vectura Clinical Trial Site 02003
Cottingham, Hull, United Kingdom
Vectura Clinical Trial site 02002
Birmingham, , United Kingdom
Vectura Clinical Trial Site 02004
Manchester, , United Kingdom
Vectura Clinical Trial Site 02001
Newcastle, , United Kingdom
Vectura Clinical Trial Site 02005
Nottingham, , United Kingdom
Countries
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Other Identifiers
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VR506/2/004
Identifier Type: -
Identifier Source: org_study_id
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