COPD Clinical Trial
Official title:
A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
This is a randomized, open-label, single-dose per dosing period, five-way crossover study in
subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global
Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent
for study participation, there will be a Screening Period lasting up to 3 weeks to determine
study eligibility and to allow for appropriate washout of prohibited medications.
Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a
minimum of a 7-day washout period between each treatment visit. At each visit, subjects will
receive one dose of study medication according to the sequence assigned.
Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on
review of the Visit predose value compared with the Screening value will be evaluated by the
investigator for continuation in the study.
Subjects taking theophylline will not be able to participate in the study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06000696 -
Healthy at Home Pilot
|
||
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
| Completed |
NCT04105075 -
COPD in Obese Patients
|
||
| Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
| Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
| Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
| Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
| Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
| Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
| Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
| Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
| Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
| Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
| Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |