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Clinical Trials/EUCTR2011-005030-19-PL
EUCTR2011-005030-19-PL
Active, not recruiting
Not Applicable

A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy - Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthma

Vectura Limited0 sites175 target enrollmentAugust 1, 2012
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ConditionsAsthmaMedDRA version: 15.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Vectura Limited
Enrollment
175
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
  • •\-Documented clinical history of severe asthma requiring oral prednisone/prednisolone therapy
  • •\-Adult asthmatic subjects having FEV1 \=40% of predicted value based on National Health and Nutrition Examination Survey (NHANES) III reference equations for United States (US) centres, and European Community for Coal and Steel (ECCS) reference equations for all other centres
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 50
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 100
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 25

Exclusion Criteria

  • •\- 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

Outcomes

Primary Outcomes

Not specified

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