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

NCT01472757 | Completed Phase 2 Results

• 1 other identifier: VR506/2/002
• Study Type: interventional
• Target: 374
• Locations: 5 countries
• Sites: 82

Brief Summary

The purpose of the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)

  Baseline and 12 weeks

Secondary Outcomes (3)

• Number of Participants With Withdrawals Due to Worsening of Asthma

  12 weeks

• Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)

  Baseline and 12 weeks

• Assessment of Acceptability of the Device

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Dose 1

ACTIVE COMPARATOR

Drug: VR506

Dose 2

ACTIVE COMPARATOR

Drug: VR506

Dose 3

ACTIVE COMPARATOR

Drug: VR506

Interventions

VR506 DRUG

VR506 inhalation powder delivered via a new dry powder inhaler

Dose 1; Dose 2; Dose 3

Placebo DRUG

Placebo delivered via a new dry powder inhaler

Placebo

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 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
• Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit
• Documented asthma reversibility in the 5 years prior to or during Screening, or if the asthma reversibility criterion is not met at Screening, then a repeat test may be carried out at the end of the Run-In Period
• Subjects with asthma who, in the opinion of the investigator, require maintenance therapy with inhaled corticosteroids (ICS), are believed to have been regularly compliant with this therapy, and are therefore likely to deteriorate within 6 weeks following withdrawal of their usual ICS treatment
• Mild or moderate asthma, defined as:
• Mild - good asthma control achieved by low-dose inhaled corticosteroid (daily dose 200-500 μg beclomethasone dipropionate or equivalent) with or without other low-intensity treatment (e.g. leukotriene modifiers or cromones) for at least 28 days before the Screening Visit
• Moderate - good asthma control achieved by low- to moderate-dose ICS (daily dose 200-1000 μg beclomethasone dipropionate or equivalent), and long acting β2-agonist (LABA) or other extra treatment, for at least 28 days before the Screening Visit
• Ability to use the new inhaler correctly, based on investigator's review of the completed inhaler operation checklist
• Ability to use the eDiary correctly, assessed by the investigator during the Screening Period
• Ability to perform technically satisfactory pulmonary function tests
• Ability to comply with study procedures, including blood sampling
• Body mass index (BMI) of 16.0 to 26.0 kg/m2 in adolescents, and in adult subjects recruited in the Philippines, and 18.0 to 32.0 kg/m2 in adults recruited in other countries
• Available to complete all study visits
• Oral peak inspiratory flow (PIF) of at least 60 L/min; using an appropriate device set to match the resistance of the new dry powder inhaler (nDPI)

You may not qualify if:

• Regular use (≥3 times per week) of topical steroids taken to treat dermatitis, rhinitis or allergic conjunctivitis, within 28 days of the Screening Visit
• Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
• Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
• History of lung cancer
• Subjects with "brittle asthma", defined as patients with asthma who either maintain over many months a wide variation (\>40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control
• History or current diagnosis of human immunodeficiency virus (HIV) infection
• Active chronic hepatitis B or C infection. If the patient's screening test is positive for hepatitis B surface antigen, the patient should be excluded unless the investigator, after a careful review of the patient's medical history and current laboratory tests of liver function, can exclude the possibility of recent or current infection
• Persistent arterial hypotension, with average systolic blood pressure (SBP) readings of ≤95 mmHg
• Subjects who have any clinically significant abnormality or 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 elevation of blood pressure, with average SBP readings of ≥160 mmHg or average diastolic blood pressure (DBP) readings of ≥100 mmHg
• Pregnant or lactating females
• Participation in another clinical study in the 28 days prior to the Screening Visit
• Current or a history of drug or alcohol abuse or dependence according to World Health Organization criteria in the 12 months prior to the Screening Visit or evidence of such abuse as indicated by laboratory assays conducted during the screening evaluation
• Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium

Sponsors & Collaborators

• Vectura Limited: lead

Study Sites (82)

Vectura Clinical Trial Site 10038

Fountain Valley, California, 92708, United States

Location

Vectura Clinical Trial Site 10031

Los Angeles, California, 90048, United States

Location

Vectura Clinical Trial Site 10044

Mission Viejo, California, 92691, United States

Location

Vectura Clinical Trial Site 10022

Orange, California, 92868, United States

Location

Vectura Clinical Trial Site 10014

Rancho Mirage, California, 92270, United States

Location

Vectura Clinical Trial Site 10027

Rolling Hills Estates, California, 90274, United States

Location

Vectura Clinical Trial Site 10033

San Jose, California, 95117, United States

Location

Vectura Clinical Trial Site 10016

Vista, California, 90283, United States

Location

Vectura Clinical Trial Site 10023

Centennial, Colorado, 80112, United States

Location

Vectura Clinical Trial Site 10001

Colorado Springs, Colorado, 80907, United States

Location

Vectura Clinical Trial Site 10025

Denver, Colorado, 80230, United States

Location

Vectura Clinical Trial Site 10041

Sarasota, Florida, 34223, United States

Location

Vectura Clinical Trial Site 10011

Albany, Georgia, 31707, United States

Location

Vectura Clinical Trial Site 10002

Metairie, Louisiana, 70006, United States

Location

Vectura Clinical Trial Site 10042

Baltimore, Maryland, 21236, United States

Location

Vectura Clinical Trial Site 10029

North Dartmouth, Massachusetts, 02747, United States

Location

Vectura Clinical Trial Site 10008

Plymouth, Minnesota, 55441, United States

Location

Vectura Clinical Trial Site 10020

Warrensburg, Missouri, 64093, United States

Location

Vectura Clinical Trial Site 10009

Missoula, Montana, 59808, United States

Location

Vectura Clinical Trial Site 10034

Bellevue, Nebraska, 68123, United States

Location

Vectura Clinical Trial Site 10035

Omaha, Nebraska, 68114, United States

Location

Vectura Clinical Trial Site 10015

Omaha, Nebraska, 68130, United States

Location

Vectura Clinical Trial Site 10040

Rochester, New York, 14618, United States

Location

Vectura Clinical Trial Site 10010

Sylvania, Ohio, 43560, United States

Location

Vectura Clinical Trial Site 10017

Oklahoma City, Oklahoma, 73103, United States

Location

Vectura Clinical Trial Site 10028

Medford, Oregon, 97504, United States

Location

Vectura Clinical Trial Site 10024

Portland, Oregon, 97202, United States

Location

Vectura Clinical Trial Site 10021

Upland, Pennsylvania, 19013, United States

Location

Vectura Clinical Trial Site 10003

Charleston, South Carolina, 29407, United States

Location

Vectura Clinical Trial Site 10019

Boerne, Texas, 78006, United States

Location

Vectura Clinical Trial Site 10039

Waco, Texas, 76712, United States

Location

Vectura Clinical Trial Site 10004

Draper, Utah, 84020, United States

Location

Vectura Clinical Trial Site 31001

Lipa City, Batangas, Philippines

Location

Vectura Clinical Trial Site 31002

Davao City, Philippines

Location

Vectura Clinical Trial Site 31003

Iloilo City, Philippines

Location

Vectura Clinical Trial Site 31004

Pasig, Philippines

Location

Vectura Clinical Trial Site 31005

Quezon City, Philippines

Location

Vectura Clinical Trial Site 31007

Quezon City, Philippines

Location

Vectura Clinical Trial Site 20018

Bialystok, 15-430, Poland

Location

Vectura Clinical Trial Site 20013

Biołystok, 15-276, Poland

Location

Vectura Clinical Trial Site 20015

Krakow, 30-510, Poland

Location

Vectura Clinical Trial Site 20019

Krakow, 31-024, Poland

Location

Vectura Clinical Trial Site 20009

Lodz, 90-553, Poland

Location

Vectura Clinical Trial Site 20012

Lublin, 20-718, Poland

Location

Vectura Clinical Trial Site 20008

Ostrów Wielkopolski, 63-400, Poland

Location

Vectura Clinical Trial Site 20003

Poznan, 60-214, Poland

Location

Vectura Clinical Trial Site 20005

Poznan, 60-823, Poland

Location

Vectura Clinical Trial Site 20016

Skiemiewice, 96-100, Poland

Location

Vectura Clinical Trial Site 20021

Tarnów, 33-100, Poland

Location

Vectura Clinical Trial Site 20010

Warsaw, 04-141, Poland

Location

Vectura Clinical Trial Site 20001

Wroclaw, 50-445, Poland

Location

Vectura Clinical Trial Site 20006

Wroclaw, 53-301, Poland

Location

Vectura Clinical Trial Site 20014

Zawadzkie, 47-120, Poland

Location

Vectura Clinical Trial Site 20007

Łodź, 90-153, Poland

Location

Vectura Clinical Trial Site 21002

Brasov, 500086, Romania

Location

Vectura Clinical Trial Site 21011

Bucharest, 050554, Romania

Location

Vectura Clinical Trial Site 21004

Cluj-Napoca, 400217, Romania

Location

Vectura Clinical Trial Site 21009

Cluj-Napoca, 400371, Romania

Location

Vectura Clinical Trial Site 21010

Cluj-Napoca, 400371, Romania

Location

Vectura Clinical Trial Site 21007

Iași, 700115, Romania

Location

Vectura Clinical Trial Site 21008

Iași, 700870, Romania

Location

Vectura Clinical Trial Site 21013

Judetul Cluj, 400371, Romania

Location

Vectura Clinical Trial Site 21012

Judetul Iasi, 700115, Romania

Location

Vectura Clinical Trial Site 21001

Târgu Mureş, 540141, Romania

Location

Vectura Clinical Trial Site 21005

Timișoara, 300689, Romania

Location

Vectura Clinical Trial Site 23013

Donetsk, 83099, Ukraine

Location

Vectura Clinical Trial Site 23005

Kharkiv, 61002, Ukraine

Location

Vectura Clinical Trial Site 23004

Kharkiv, 61051, Ukraine

Location

Vectura Clinical Trial Site 23010

Kharkiv, 61124, Ukraine

Location

Vectura Clinical Trial Site 23012

Kiev, 02232, Ukraine

Location

Vectura Clinical Trial Site 23002

Kiev, 03680, Ukraine

Location

Vectura Clinical Trial Site 23009

Kiev, 03680, Ukraine

Location

Vectura Clinical Trial Site 23011

Kiev, 03680, Ukraine

Location

Vectura Clinical Trial Site 23017

Kiev, 03680, Ukraine

Location

Vectura Clinical Trial Site 23001

Kyiv, 04050, Ukraine

Location

Vectura Clinical Trial Site 23003

Kyiv, 04050, Ukraine

Location

Vectura Clinical Trial Site 23018

Kyiv, 04201, Ukraine

Location

Vectura Clinical Trial Site 23007

Odesa, 65031, Ukraine

Location

Vectura Clinical Trial Site 23015

Simferopol, 95034, Ukraine

Location

Vectura Clinical Trial Site 23014

Vinnytsia, 21029, Ukraine

Location

Vectura Clinical Trial Site 23008

Zaporizhzhya, 69063, Ukraine

Location

Vectura Clinical Trial Site 23016

Zaporizhzhya, 69118, Ukraine

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

Study Officials

• Ronald Dahl, Dr.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

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: November 11, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

PL (16); RO (11); US (32); UA (17); PH (6)