Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03243760

Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
A Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Capsules for Inhalation in Healthy Subjects and Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Summary

This study will be the first administration of CCI15106 capsules for inhalation to humans. The primary objective of the study is to investigate the safety and tolerability of single and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD). The intention of this study is to provide sufficient confidence in the safety of the molecule delivered by inhalation to inform progression to further repeat dose and proof of concept studies.

This will be a three-part study. Part 1 will investigate single ascending doses and Part 2 repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to patients with moderate COPD.

There will be screening period of up to 30 days. The treatment period will be 3 days for Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the last dose.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03243760
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 1
Start date February 10, 2016
Completion date August 20, 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT05043428 - The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD N/A
Completed NCT00528996 - An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler. Phase 2
Completed NCT03740373 - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate Phase 1
Completed NCT05393245 - Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Completed NCT05402020 - Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Completed NCT04011735 - Re-usable Respimat® Soft MistTM Inhaler Study
Enrolling by invitation NCT03075709 - The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Completed NCT03764163 - Image and Model Based Analysis of Lung Disease Early Phase 1
Completed NCT00515268 - Endotoxin Challenge Study For Healthy Men and Women Phase 1
Completed NCT04085302 - TARA Working Prototype Engagement Evaluation: Feasibility Study N/A
Completed NCT03691324 - Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study N/A
Completed NCT02236611 - A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT00153075 - Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT01009463 - A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01017952 - A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT04882124 - Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD Phase 2
Completed NCT02853123 - Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients Phase 4
Completed NCT02619357 - Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma Phase 1
Recruiting NCT05858463 - High Intensity Interval Training and Muscle Adaptations During PR N/A
Not yet recruiting NCT05032898 - Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II