A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated with Human Rhinovirus Type 16

Completed

• Conditions: asthma chronic lung inflammation; 10024967

• Registration Number: NL-OMON39844
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive at the time of signing the informed consent
-Have a body mass index (BMI) of 19 to 40 kg/m2 inclusive.
- Have a physician documented diagnosis of asthma for at least 6 months prior to Screening Visit 2.
- Have objective evidence of asthma by fulfilling 1 of the following 4 criteria below. Only
1 of these 4 criteria below needs to be fulfilled:
• An increase in FEV1 of 12% or greater and at least a 200 mL within 30 minutes after administration of up to 8 puffs of a short-acting β2-agonist (SABA) at Screening Visit 2,
• -documented increase in FEV1 of 12% or greater and at least a 200 mL within 30 minutes after administration of up to 8 puffs of a SABA within 36 months before Screening Visit 1
• -documented airway reactivity to histamine (PC20 histamine < or equal 8 mg/mL) or methacholine (PC20 methacholine < or equal 16 mg/mL) within 36 months prior to screening visit 1
• Airway reactivity to histamine (PC20 histamine < or equal 8mg/ml) or methacholine (PC20 methacholine < or equal 16 mg/ml assessed between screening visit 2 and prior to day 1.
- Have stable asthma based on physician assessment at Screening Visit 2.
• Permitted concomitant medications for asthma must have been at a stable dose for the 4 weeks prior to Screening Visit 1.
- Have a prebronchodilator forced expiratory volume in the first second (FEV1) >= 65% of predicted normal value at Screening Visit 2.

Exclusion Criteria

- Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator.
- Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma.
- Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1.
- Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids.
- Is receiving high dose ICS (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (<=500 µg/day fluticasone or equivalent) with or without permitted controller medications e.g LABA, LTRA is allowed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified