Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma

NCT01720069 | Completed Phase 2 Results

• 1 other identifier: VR506/2/004
• Study Type: interventional
• Target: 197
• Locations: 8 countries
• Sites: 77

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)

  The mean asthma control prednisone/prednisolone dose at end of study (week 16)

  16 weeks

Secondary Outcomes (6)

• 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)

  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

  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)

  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

  Baseline and 16 weeks

• Number of Participants With Withdrawals Due to Worsening of Asthma

  16 weeks

Study Arms (3)

Dose 1 VR506

ACTIVE COMPARATOR

VR506 inhalation powder delivered via a new dry powder inhaler device

Drug: VR506

Dose 2 VR506

ACTIVE COMPARATOR

VR506 inhalation powder delivered via a new dry powder inhaler device

Drug: VR506

Dose 3 VR506

ACTIVE COMPARATOR

VR506 inhalation powder delivered via a new dry powder inhaler device

Drug: VR506

Interventions

VR506 DRUG

VR506 inhalation powder delivered via a new dry powder inhaler device

Dose 1 VR506; Dose 2 VR506; Dose 3 VR506

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vectura Limited: lead

Study Sites (77)

Vectura Clinical Trial Site 01001

Los Angeles, California, 90025, United States

Location

Vectura Clinial Trial Site 01005

Denver, Colorado, 80206, United States

Location

Vectura Clinical Trial Site 01006

Celebration, Florida, 34747, United States

Location

Vectura Clinical Trial Site 01015

Hialeah, Florida, 33018, United States

Location

Vectura Clinical Trial Site 01012

Miami Lakes, Florida, 33016, United States

Location

Vectura Clinical Trial Site 01014

Orlando, Florida, 32806, United States

Location

Vectura Clinical Trial Site 01003

Tampa, Florida, 33613, United States

Location

Vectura Clinical Trial Site 01011

St Louis, Missouri, 63110-1093, United States

Location

Vectura Clinical Trial Site 01013

Jersey City, New Jersey, 07306, United States

Location

Vectura Clinical Trial Site 01004

The Bronx, New York, 10461, United States

Location

Vectura Clinical Trial Site 01007

El Paso, Texas, 79925, United States

Location

Vectura Clinical Trial Site 08006

Rousse, 7000, Bulgaria

Location

Vectura Clinical Trial Site 08005

Sofia, 1000, Bulgaria

Location

Vectura Clinical Trial Site 08001

Sofia, 1431, Bulgaria

Location

Vectura Clinical Trial Site 08003

Sofia, 1431, Bulgaria

Location

Vectura Clinical Trial Site 08007

Sofia, 1431, Bulgaria

Location

Vectura Clinical Trial Site 08004

Sofia, 1606, Bulgaria

Location

Vectura Clinical Trial Site 08002

Stara Zagora, 6000, Bulgaria

Location

Vectura Clinical Trial Site 08008

Varna, 9000, Bulgaria

Location

Vectura Clinical Trial Site 03006

Berlin, 10717, Germany

Location

Vectura Clinical Trial Site 03009

Berlin, 12203, Germany

Location

Vectura Clinical Trial Site 03004

Bonn, 53119, Germany

Location

Vectura Clinical Trial Site 03008

Donaustauf, 93093, Germany

Location

Vectura Clinical Trial Site 03003

Dortmund, 44263, Germany

Location

Vectura Clinical Trial Site 03007

Geesthacht, 21502, Germany

Location

Vectura Clinical Trial Site 03001

Hamburg, 22767, Germany

Location

Vectura Clinical Trial Site 03005

Heidelberg, 69126, Germany

Location

Vectura Clinical Trial Site 03002

Rüdersdorf, 15562, Germany

Location

Vectura Clinical Trial Site 04001

Budapest, 1121, Hungary

Location

Vectura Clinical Trial Site 04004

Budapest, 1125, Hungary

Location

Vectura Clinical Trial Site 04003

Debrecen, 4032, Hungary

Location

Vectura Clinical Trial Site 04002

Rakoczi, 125 127, Hungary

Location

Vectura Clinical Trial Site 04005

Rakoczi, 7100, Hungary

Location

Vectura Clinical Trial Site 05008

Bialystok, 15-003, Poland

Location

Vectura Clinical Trial Site 05002

Bialystok, 15-276, Poland

Location

Vectura Clinical Trial Site 05010

Bialystok, 15-430, Poland

Location

Vectura Clinical Trial Site 05011

Krakow, 31-024, Poland

Location

Vectura Clinical Trial Site 05001

Lodz, 90-153, Poland

Location

Vectura Clinical Trial Site 05006

Lodz, 90-153, Poland

Location

Vectura Clinical Trial Site 05005

Lublin, 20-552, Poland

Location

Vectura Clinical Trial Site 05007

Tarnów, 33-100, Poland

Location

Vectura Clinical Trial Site 05003

Warsaw, 02-097, Poland

Location

Vectura Clinical Trial Site 05009

Wroclaw, 51-162, Poland

Location

Vectura Clinical Trial Site 05004

Zawadzkie, 47-120, Poland

Location

Vectura Clinical Trial Site 07001

Brasov, 500086, Romania

Location

Vectura Clinical Trial Site 07008

Bucharest, 010457, Romania

Location

Vectura Clinical Trial Site 07005

Bucharest, 020671, Romania

Location

Vectura Clinical Trial Site 07013

Bucharest, 030303, Romania

Location

Vectura Clinical Trial Site 07003

Bucharest, 050554, Romania

Location

Vectura Clinical Trial Site 07006

Cluj-Napoca, 400371, Romania

Location

Vectura Clinical Trial Site 07007

Cluj-Napoca, 400371, Romania

Location

Vectura Clinical Trial Site 07009

Cluj-Napoca, 400371, Romania

Location

Vectura Clinical Trial Site 07014

Craiova, 200515, Romania

Location

Vectura Clinical Trial Site 07002

Iași, 700376, Romania

Location

Vectura Clinical Trial Site 07004

Marghita, 415300, Romania

Location

Vectura Clinical Trial Site 07010

Sadu, 700115, Romania

Location

Vectura Clinical Trial Site 07012

Târgu Mureş, 540543, Romania

Location

Vectura Clinicl Trial Site 07011

Timuș, 300310, Romania

Location

Vectura Clinical Trial Site 06013

AR Crimea, 97403, Ukraine

Location

Vectura Clinical Trial Site 06009

Donetsk, 83099, Ukraine

Location

Vectura Clinical Trial Site 06012

Ivano-Frankivsk, 76018, Ukraine

Location

Vectura Clinical Trial Site 06010

Kharkiv, 61002, Ukraine

Location

Vectura Clinical Trial Site 06001

Kharkiv, 61035, Ukraine

Location

Vectura Clinical Trial Site 06004

Kharkiv, 61106, Ukraine

Location

Vectura Clinical Trial Site 06006

Kyiv, 02232, Ukraine

Location

Vectura Clinical Trial Site 06002

Kyiv, 03680, Ukraine

Location

Vectura Clinical Trial Site 06015

Kyiv, 3680, Ukraine

Location

Vectura Clinical Trial Site 06003

Kyviv, 04050, Ukraine

Location

Vectura Clinical Trial Site 06008

Mykolaiv, 54003, Ukraine

Location

Vectura Clinical Trial Site 06011

Vinnitsa, 21029, Ukraine

Location

Vectura Clinical Trial Site 06007

Zaporizhzhia, 69600, Ukraine

Location

Vectura Clinical Trial Site 06014

Zaporizhzhya, 69118, Ukraine

Location

Vectura Clinical Trial Site 02003

Cottingham, Hull, HU16 5JQ, United Kingdom

Location

Vectura Clinical Trial site 02002

Birmingham, B9 5SS, United Kingdom

Location

Vectura Clinical Trial Site 02004

Manchester, M23 9LT, United Kingdom

Location

Vectura Clinical Trial Site 02001

Newcastle, NE7 7DN, United Kingdom

Location

Vectura Clinical Trial Site 02005

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Gary Burgess, MD
• Organization: Vectura Limited

clinical.enquiries@vectura.com

+44(0)1249 667700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

DE (9); UA (14); BU (8); PL (11); HU (5); RO (14); US (11); GB (5)