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AsthmaPhase 2/3NCT01720069

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

A Phase 2/3 study testing VR506 in people with Asthma, run by Vectura Limited at 77 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Asthma
What is being tested?
VR506
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
77 sitesin 8 countries
Study dates
Oct 2012to Oct 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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)].

Who cannot join

  • 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
Show all 23Show fewer
  • 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)

Trial locations and contacts

77 sites in 8 countries.

77 sites in 8 countries

Romania14 sites

  • Vectura Clinical Trial Site 07001

    Brasov, 500086

  • Vectura Clinical Trial Site 07008

    Bucharest, 010457

  • Vectura Clinical Trial Site 07005

    Bucharest, 020671

  • Vectura Clinical Trial Site 07013

    Bucharest, 030303

  • Vectura Clinical Trial Site 07003

    Bucharest, 050554

  • Vectura Clinical Trial Site 07006

    Cluj-Napoca, 400371

  • Vectura Clinical Trial Site 07007

    Cluj-Napoca, 400371

  • Vectura Clinical Trial Site 07009

    Cluj-Napoca, 400371

  • Vectura Clinical Trial Site 07014

    Craiova, 200515

  • Vectura Clinical Trial Site 07002

    Iași, 700376

  • Vectura Clinical Trial Site 07004

    Marghita, 415300

  • Vectura Clinical Trial Site 07010

    Sadu, 700115

  • Vectura Clinical Trial Site 07012

    Târgu Mureş, 540543

  • Vectura Clinicl Trial Site 07011

    Timuș, 300310

Other trials in Romania

Ukraine14 sites

  • Vectura Clinical Trial Site 06013

    AR Crimea, 97403

  • Vectura Clinical Trial Site 06009

    Donetsk, 83099

  • Vectura Clinical Trial Site 06012

    Ivano-Frankivsk, 76018

  • Vectura Clinical Trial Site 06010

    Kharkiv, 61002

  • Vectura Clinical Trial Site 06001

    Kharkiv, 61035

  • Vectura Clinical Trial Site 06004

    Kharkiv, 61106

  • Vectura Clinical Trial Site 06006

    Kyiv, 02232

  • Vectura Clinical Trial Site 06002

    Kyiv, 03680

  • Vectura Clinical Trial Site 06015

    Kyiv, 3680

  • Vectura Clinical Trial Site 06003

    Kyviv, 04050

  • Vectura Clinical Trial Site 06008

    Mykolaiv, 54003

  • Vectura Clinical Trial Site 06011

    Vinnitsa, 21029

  • Vectura Clinical Trial Site 06014

    Zaporizhzhya, 69118

  • Vectura Clinical Trial Site 06007

    Zaporizhzhya, 69600

Other trials in Ukraine

United States11 sites

  • Vectura Clinical Trial Site 01006

    Celebration, Florida, 34747

  • Vectura Clinial Trial Site 01005

    Denver, Colorado, 80206

  • Vectura Clinical Trial Site 01007

    El Paso, Texas, 79925

  • Vectura Clinical Trial Site 01015

    Hialeah, Florida, 33018

  • Vectura Clinical Trial Site 01013

    Jersey City, New Jersey, 07306

  • Vectura Clinical Trial Site 01001

    Los Angeles, California, 90025

  • Vectura Clinical Trial Site 01012

    Miami Lakes, Florida, 33016

  • Vectura Clinical Trial Site 01014

    Orlando, Florida, 32806

  • Vectura Clinical Trial Site 01011

    St Louis, Missouri, 63110-1093

  • Vectura Clinical Trial Site 01003

    Tampa, Florida, 33613

  • Vectura Clinical Trial Site 01004

    The Bronx, New York, 10461

Other trials in United States

Poland11 sites

  • Vectura Clinical Trial Site 05008

    Bialystok, 15-003

  • Vectura Clinical Trial Site 05002

    Bialystok, 15-276

  • Vectura Clinical Trial Site 05010

    Bialystok, 15-430

  • Vectura Clinical Trial Site 05011

    Krakow, 31-024

  • Vectura Clinical Trial Site 05001

    Lodz, 90-153

  • Vectura Clinical Trial Site 05006

    Lodz, 90-153

  • Vectura Clinical Trial Site 05005

    Lublin, 20-552

  • Vectura Clinical Trial Site 05007

    Tarnów, 33-100

  • Vectura Clinical Trial Site 05003

    Warsaw, 02-097

  • Vectura Clinical Trial Site 05009

    Wroclaw, 51-162

  • Vectura Clinical Trial Site 05004

    Zawadzkie, 47-120

Other trials in Poland

Germany9 sites

  • Vectura Clinical Trial Site 03006

    Berlin, 10717

  • Vectura Clinical Trial Site 03009

    Berlin, 12203

  • Vectura Clinical Trial Site 03004

    Bonn, 53119

  • Vectura Clinical Trial Site 03008

    Donaustauf, 93093

  • Vectura Clinical Trial Site 03003

    Dortmund, 44263

  • Vectura Clinical Trial Site 03007

    Geesthacht, 21502

  • Vectura Clinical Trial Site 03001

    Hamburg, 22767

  • Vectura Clinical Trial Site 03005

    Heidelberg, 69126

  • Vectura Clinical Trial Site 03002

    Rüdersdorf, 15562

Other trials in Germany

Bulgaria8 sites

  • Vectura Clinical Trial Site 08006

    Rousse, 7000

  • Vectura Clinical Trial Site 08005

    Sofia, 1000

  • Vectura Clinical Trial Site 08001

    Sofia, 1431

  • Vectura Clinical Trial Site 08003

    Sofia, 1431

  • Vectura Clinical Trial Site 08007

    Sofia, 1431

  • Vectura Clinical Trial Site 08004

    Sofia, 1606

  • Vectura Clinical Trial Site 08002

    Stara Zagora, 6000

  • Vectura Clinical Trial Site 08008

    Varna, 9000

Other trials in Bulgaria

Hungary5 sites

  • Vectura Clinical Trial Site 04001

    Budapest, 1121

  • Vectura Clinical Trial Site 04004

    Budapest, 1125

  • Vectura Clinical Trial Site 04003

    Debrecen, 4032

  • Vectura Clinical Trial Site 04002

    Rakoczi, 125 127

  • Vectura Clinical Trial Site 04005

    Rakoczi, 7100

Other trials in Hungary

United Kingdom5 sites

  • Vectura Clinical Trial site 02002

    Birmingham, B9 5SS

  • Vectura Clinical Trial Site 02003

    Cottingham, Hull, HU16 5JQ

  • Vectura Clinical Trial Site 02004

    Manchester, M23 9LT

  • Vectura Clinical Trial Site 02001

    Newcastle, NE7 7DN

  • Vectura Clinical Trial Site 02005

    Nottingham, NG5 1PB

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Asthma
Being tested
VR506
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR506Drug

    VR506 inhalation powder delivered via a new dry powder inhaler device

Study groups in NCT01720069
Study groupRoleWhat they receive
Dose 1 VR506Active comparatorVR506 inhalation powder delivered via a new dry powder inhaler device
Receives: Drug: VR506
Dose 2 VR506Active comparatorVR506 inhalation powder delivered via a new dry powder inhaler device
Receives: Drug: VR506
Dose 3 VR506Active comparatorVR506 inhalation powder delivered via a new dry powder inhaler device
Receives: Drug: VR506

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 16 weeks

Secondary outcomes (6)

  1. 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)

    Measured: Baseline and 16 weeks

  2. Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score

    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).

    Measured: Baseline and 16 weeks

  3. Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)

    Measured: Baseline and 16 weeks

  4. Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score

    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).

    Measured: Baseline and 16 weeks

  5. Number of Participants With Withdrawals Due to Worsening of Asthma

    Measured: 16 weeks

  6. Assessment of Acceptability of the Device

    Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720069
Sponsor's protocol ID
VR506/2/004
Status last verified
Apr 2020
First submitted
30 Oct 2012
Last updated
21 Apr 2020

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VR506 in people with Asthma, run by Vectura Limited at 77 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Romania, Ukraine, United States, Poland, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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