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

April 9, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Ruse, Bulgaria, 7000
        • Vectura Clinical Trial Site 08006
      • Sofia, Bulgaria, 1000
        • Vectura Clinical Trial Site 08005
      • Sofia, Bulgaria, 1431
        • Vectura Clinical Trial Site 08001
      • Sofia, Bulgaria, 1431
        • Vectura Clinical Trial Site 08003
      • Sofia, Bulgaria, 1431
        • Vectura Clinical Trial Site 08007
      • Sofia, Bulgaria, 1606
        • Vectura Clinical Trial Site 08004
      • Stara Zagora, Bulgaria, 6000
        • Vectura Clinical Trial Site 08002
      • Varna, Bulgaria, 9000
        • Vectura Clinical Trial Site 08008
  • Germany
      • Berlin, Germany, 10717
        • Vectura Clinical Trial Site 03006
      • Berlin, Germany, 12203
        • Vectura Clinical Trial Site 03009
      • Bonn, Germany, 53119
        • Vectura Clinical Trial Site 03004
      • Donaustauf, Germany, 93093
        • Vectura Clinical Trial Site 03008
      • Dortmund, Germany, 44263
        • Vectura Clinical Trial Site 03003
      • Geesthacht, Germany, 21502
        • Vectura Clinical Trial Site 03007
      • Hamburg, Germany, 22767
        • Vectura Clinical Trial Site 03001
      • Heidelberg, Germany, 69126
        • Vectura Clinical Trial Site 03005
      • Rudersdorf, Germany, 15562
        • Vectura Clinical Trial Site 03002
  • Hungary
      • Budapest, Hungary, 1121
        • Vectura Clinical Trial Site 04001
      • Budapest, Hungary, 1125
        • Vectura Clinical Trial Site 04004
      • Debrecen, Hungary, 4032
        • Vectura Clinical Trial Site 04003
      • Rakoczi, Hungary, 125 127
        • Vectura Clinical Trial Site 04002
      • Rakoczi, Hungary, 7100
        • Vectura Clinical Trial Site 04005
  • Poland
      • Bialystok, Poland, 15-003
        • Vectura Clinical Trial Site 05008
      • Bialystok, Poland, 15-276
        • Vectura Clinical Trial Site 05002
      • Bialystok, Poland, 15-430
        • Vectura Clinical Trial Site 05010
      • Krakow, Poland, 31-024
        • Vectura Clinical Trial Site 05011
      • Lodz, Poland, 90-153
        • Vectura Clinical Trial Site 05001
      • Lodz, Poland, 90-153
        • Vectura Clinical Trial Site 05006
      • Lublin, Poland, 20-552
        • Vectura Clinical Trial Site 05005
      • Tarnow, Poland, 33-100
        • Vectura Clinical Trial Site 05007
      • Warszawa, Poland, 02-097
        • Vectura Clinical Trial Site 05003
      • Wroclaw, Poland, 51-162
        • Vectura Clinical Trial Site 05009
      • Zawadzkie, Poland, 47-120
        • Vectura Clinical Trial Site 05004
  • Romania
      • Brasov, Romania, 500086
        • Vectura Clinical Trial Site 07001
      • Bucuresti, Romania, 010457
        • Vectura Clinical Trial Site 07008
      • Bucuresti, Romania, 020671
        • Vectura Clinical Trial Site 07005
      • Bucuresti, Romania, 030303
        • Vectura Clinical Trial Site 07013
      • Bucuresti, Romania, 050554
        • Vectura Clinical Trial Site 07003
      • Cluj-Napoca, Romania, 400371
        • Vectura Clinical Trial Site 07006
      • Cluj-Napoca, Romania, 400371
        • Vectura Clinical Trial Site 07007
      • Cluj-Napoca, Romania, 400371
        • Vectura Clinical Trial Site 07009
      • Cod, Romania, 700115
        • Vectura Clinical Trial Site 07010
      • Craiova, Romania, 200515
        • Vectura Clinical Trial Site 07014
      • Iasi, Romania, 700376
        • Vectura Clinical Trial Site 07002
      • Marghita, Romania, 415300
        • Vectura Clinical Trial Site 07004
      • Targu Mures, Romania, 540543
        • Vectura Clinical Trial Site 07012
      • Timis, Romania, 300310
        • Vectura Clinicl Trial Site 07011
  • Ukraine
      • 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
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Vectura Clinical Trial site 02002
      • Manchester, United Kingdom, M23 9LT
        • Vectura Clinical Trial Site 02004
      • Newcastle, United Kingdom, NE7 7DN
        • Vectura Clinical Trial Site 02001
      • Nottingham, United Kingdom, NG5 1PB
        • Vectura Clinical Trial Site 02005
    • Hull
      • Cottingham, Hull, United Kingdom, HU16 5JQ
        • Vectura Clinical Trial Site 02003
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Vectura Clinical Trial Site 01001
    • Colorado
      • Denver, Colorado, United States, 80206
        • Vectura Clinial Trial Site 01005
    • Florida
      • Celebration, Florida, United States, 34747
        • Vectura Clinical Trial Site 01006
      • Hialeah, Florida, United States, 33018
        • Vectura Clinical Trial Site 01015
      • Miami Lakes, Florida, United States, 33016
        • Vectura Clinical Trial Site 01012
      • Orlando, Florida, United States, 32806
        • Vectura Clinical Trial Site 01014
      • Tampa, Florida, United States, 33613
        • Vectura Clinical Trial Site 01003
    • Missouri
      • Saint Louis, Missouri, United States, 63110-1093
        • Vectura Clinical Trial Site 01011
    • New Jersey
      • Jersey City, New Jersey, United States, 07306
        • Vectura Clinical Trial Site 01013
    • New York
      • Bronx, New York, United States, 10461
        • Vectura Clinical Trial Site 01004
    • Texas
      • El Paso, Texas, United States, 79925
        • Vectura Clinical Trial Site 01007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Drug: VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Active Comparator: Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Drug: VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Active Comparator: Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Drug: VR506
VR506 inhalation powder delivered via a new dry powder inhaler device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Time Frame: 16 weeks
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 16 weeks
16 weeks
Assessment of Acceptability of the Device
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vectura Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR506/2/004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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