Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
- Conditions
- AsthmaChronic Obstructive Pulmonary Disease
- Interventions
- Drug: SelK2 (Part 1)Drug: Placebo (Part 1)Drug: SelK2 (Part 2)Drug: Placebo (Part 2)
- Registration Number
- NCT04540042
- Lead Sponsor
- Tetherex Pharmaceuticals Corporation
- Brief Summary
This study has two parts. The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD). Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SelK2 (Part 1) SelK2 (Part 1) I.V., multiple-dose (Day 1 and Day 22) Placebo (Part 1) Placebo (Part 1) I.V., multiple-dose (Day 1 and Day 22) SelK2 (Part 2) SelK2 (Part 2) I.V., single-dose (Day 1) Placebo (Part 2) Placebo (Part 2) I.V., single-dose (Day 1)
- Primary Outcome Measures
Name Time Method Change from baseline in percentage of neutrophils in sputum (Part 2). Change from baseline to Day 22 Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1). Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
- Secondary Outcome Measures
Name Time Method Change from baseline and change during challenge in percentage of eosinophils in sputum (Part 1) Change from baseline to 8 and 24 hours post allergen challenge Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 from pre-challenge between 0 and 2 hours after the administration of allergen inhalation challenge (EAR) (Part 1). Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 between 0 and 8 hours (entire asthmatic response) after the administration of allergen inhalation challenge (Part 1) Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge Change from baseline in percentage of neutrophils (Part 2). Change from baseline to Days 4, 8, 15, and 29 Change from baseline in pre-challenge FEV1 (Part 1). Change from baseline to Day 29 AUC for the percent fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after the administration of allergen inhalation challenge (Part 1). Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge Change from baseline in absolute and percentage cell counts for immune cells in induced sputum samples and blood (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Scores range from 0-12 with 12 being associated with the worst outcome.
Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Change from baseline in COPD Assessment Test (CAT) scores (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29 Scores range from 0-40 with 40 being associated with the worst outcome.
Trial Locations
- Locations (2)
Medicines Evaluation Unit Ltd.
🇬🇧Manchester, United Kingdom
Queen Anne Street Medical Centre
🇬🇧London, United Kingdom