Efficacy and safety of QGE031 versus placebo in patients aged 18-75 years with asthma not adequately controlled with standard of care medication (inhaled corticosteroids plus long lasting beta agonists with or without oral corticosteroids)

Phase 1

• Conditions: Severe Asthma; MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003155-57-IT
• Lead Sponsor: OVARTIS FARMA S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-21
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

A diagnosis of allergic asthma, uncontrolled on current medication.
•History of at least 2 asthma exacerbations during the last 1 year
•Forced Expiratory Volume in one second (FEV1) of = 40% and = 80%
of the predicted normal value; reversibility following administration of
bronchodilator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

Exclusion Criteria

History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin or in-situ cervical cancer) within the past 5 years
? Patients who have smoked or inhaled tobacco products within 6 month period
prior to Visit 1, or who have a smoking history of greater than 10 pack years.
? Patients who have had an asthma attack/exacerbation requiring a short burst
of SCSs for at least 3 continuous days within 6 weeks prior to Visit 1
? Patients who have had a respiratory tract infection within 4 weeks prior to
Visit 1
? History of life-threatening asthma in the previous ten years
? History or active of chronic lung diseases other than asthma
? Pregnant or nursing (lactating) women
? Women of child-bearing potential without effective contraception methods

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified