A Two Part, Randomised, Double-blind, Placebo-controlled, Phase 2 Parallel Group Study to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
Overview
- Phase
- Phase 2
- Intervention
- SelK2 (Part 1)
- Conditions
- Asthma
- Sponsor
- Tetherex Pharmaceuticals Corporation
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Change from baseline in percentage of neutrophils in sputum (Part 2).
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SelK2 (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
Intervention: SelK2 (Part 1)
Placebo (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
Intervention: Placebo (Part 1)
SelK2 (Part 2)
I.V., single-dose (Day 1)
Intervention: SelK2 (Part 2)
Placebo (Part 2)
I.V., single-dose (Day 1)
Intervention: Placebo (Part 2)
Outcomes
Primary Outcomes
Change from baseline in percentage of neutrophils in sputum (Part 2).
Time Frame: 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).
Time Frame: Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
Secondary Outcomes
- 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)
- 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)