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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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