Effects of anti-TSLP on airway hyperresponsiveness and mast cell phenotype in asthma- A randomized double-blind, placebo-controlled trial of MEDI9929The UPSTREAM study

Phase 1

• Conditions: Asthma; MedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-005542-56-DK
• Lead Sponsor: Copenhagen University Hospital Bispebjerg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Written informed consent
2.Age 18 through 75, inclusive at the time of Visit 1
3.Body mass index between 18-40 kg/m2 (both inclusive) and weight = 40 kg at Visit 1.
4.A diagnosis of asthma as defined by GINA (ginasthma.org).
5.ICS (in any dose) on a daily basis for at least three months prior to Visit 1
6.A stable asthma controller regimen with ICS (±LABA) for at least 4 weeks prior to Visit 1
7.A FEV1 value of = 70% at Visit 1
8.ACQ-6 > 1 (partly controlled) at Visit 1
9.PD15 to mannitol <= 315 mg at visit 1

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 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Current smokers or subjects with a smoking history of = 10 pack years. Former smokers with < 10 pack years must have stopped for at least 6 months to be eligible.
2.Previous medical history or evidence of an uncontrolled intercurrent illness.
3.Any clinically relevant abnormal findings in hematology or clinical chemistry.
4.Evidence of active liver disease.
5.History of cancer.
6.Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to Visit 1.
7.A helminth parasitic infection diagnosed within 24 weeks of Visit 1.
8.Known history of active tuberculosis (TB).
9.Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening.
10.Oral corticosteroids (any dose for more than 3 days) 12 weeks prior to Visit 1 or during the run-in period.
11.Pregnant, breastfeeding or lactating females.
12. Concomitant respiratory disease

Study & Design

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