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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vectura Limited
ClinicalTrials.gov Identifier:
NCT01720069
First received: October 30, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: VR506
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Vectura Limited:

Primary Outcome Measures:
  • Mean Prednisone/Prednisolone Dose for Analysis (PDA) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The Asthma Control Prednisone/Prednisolone Dose at end of study


Secondary Outcome Measures:
  • In clinic measurements of FEV1, asthma control (ACQ) and Quality of Life and use of asthma control questionnaires [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of VR506 in subjects with asthma [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Measure of vital signs, AEs, SAEs and number of withdrawals for worsening asthma

  • To evaluate the subject's operation and handling of the nDPI [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Assessment of the Compliance with the treatment regimen; operation and acceptability of the device by use of questionnaire


Enrollment: 197
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720069

  Show 77 Study Locations
Sponsors and Collaborators
Vectura Limited
  More Information

No publications provided

Responsible Party: Vectura Limited
ClinicalTrials.gov Identifier: NCT01720069     History of Changes
Other Study ID Numbers: VR506/2/004
Study First Received: October 30, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014