At a glance
ClinicalIndex Comparison Record- ✓Age 40–70 years
- ✓Confirmed COPD diagnosis for >6 months
- ✓Current or former smoker with ≥10 pack-year history
- ✕Poorly controlled or unstable COPD
- ✕Any uncontrolled medical condition or disease
- ✕Respiratory tract infection treated with antibiotics within 4 weeks prior to screening
- ✕Regular oral corticosteroids or oral/parenteral corticosteroids within 4 weeks prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled, Single and Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Inhaled GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 1 clinical trial evaluating GSK3923868 and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.
Study Details
Timeline
Interventions
GSK3923868 will be administered
Placebo will be administered