Clinical trials: Delivery Systems
Asthma
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.
- Trial name
- NCT00403754
- Testing
- Indacaterol, Salmeterol
- Where
- 8 sites in Japan
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Diphtheria, Hepatitis B
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT02853929
- Testing
- Infanrix hexa
- Where
- 29 sites in Australia, Canada and 4 more
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 1 Diabetes Mellitus
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes.
- Trial name
- NCT01421225
- Testing
- Closed-loop Insulin Pump therapy, Standard Insulin Pump Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
Asthma
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium…
- Trial name
- NCT00353873
- Testing
- Fluticasone propionate, Fluticasone propionate/salmeterol
- Where
- 65 sites in Belgium, Denmark and 10 more
- Volunteers
- 506 people
- Sponsor
- GlaxoSmithKline
Attentional Bias, Smoking Cues
Trial on the Effect of E-cigarette Advertising on Cigarette Perceptions in Adolescents
This research aims to investigate how exposure to advertising for Electronic Nicotine Delivery Systems (commonly called e-cigarettes) may lead to combustible smoking initiation in adolescents.
- Conditions
- Attentional Bias, Smoking Cues, Positive Perceptions About Cigarette Smoking, Social Norms
- Trial name
- NCT03786042
- Testing
- E-cigarette ad exposure, non e-cigarette TV commercials
- Where
- United States
- Volunteers
- 139 people
- Sponsor
- Trustees of Dartmouth College
Type 1 Diabetes
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
- Trial name
- NCT00519623
- Testing
- PassPort(R) Transdermal Insulin Delivery System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Altea Therapeutics
Asthma
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo.
- Trial name
- NCT00776984
- Testing
- tiotropium 5mcg/day
- Where
- 75 sites in United States, Australia and 13 more
- Volunteers
- 453 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities…
- Trial name
- NCT04714216
- Testing
- The Omnipod 5/Horizon HCL system
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Emory University
Alpha 1-Antitrypsin Deficiency
Safety Dose Finding Study of ADVM-043 Gene Therapy to Treat Alpha-1 Antitrypsin (A1AT) Deficiency
The ADVANCE study is being conducted by Adverum Biotechnologies, Inc. as an open-label, multicenter, dose-escalation study in order to assess the safety and protein expression of ADVM-043 following a single intravenous or…
- Trial name
- ADVANCE (NCT02168686)
- Testing
- ADVM-043
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Adverum Biotechnologies, Inc.
Hepatitis B
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants.
- Trial name
- NCT06058390
- Testing
- Bepirovirsen
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease…
- Trial name
- NCT02059434
- Testing
- LAS190792 Dose 1, LAS190792 Dose 2, LAS190792 Dose 3
- Where
- 2 sites in United Kingdom
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Diabetic Peripheral Neuropathy, Pain
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
- Trial name
- STEP (NCT01533428)
- Testing
- Capsaicin 8%
- Where
- 29 sites in United States
- Volunteers
- 369 people
- Sponsor
- Astellas Pharma Inc
Management of Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
- Trial name
- NCT01709721
- Testing
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Piramal Critical Care, Ltd.
Asthma
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
- Trial name
- NCT05602025
- Testing
- Depemokimab
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.
- Trial name
- NCT02031640
- Testing
- Beclomethasone dipropionate, Albuterol/salbutamol
- Where
- 131 sites in United States, Germany and 2 more
- Volunteers
- 1,113 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Duchenne Muscular Dystrophy, Cardiomyopathy
HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)
Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age.
- Trial name
- HOPE (NCT02485938)
- Testing
- Allogeneic Cardiosphere-Derived Cells (CAP-1002)
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Capricor Inc.
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
HLA-A2 Positive Cells Present, Metastatic Malignant Neoplasm
Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes
This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and…
- Conditions
- HLA-A2 Positive Cells Present, Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
- Trial name
- NCT02774291
- Testing
- Aldesleukin, Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes, Cyclophosphamide
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Albert Einstein College of Medicine
Healthy Subjects
Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers
Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process…
- Trial name
- NCT04617782
- Testing
- Donepezil TDS, Aricept
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Corium, Inc.
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
This research study is for subjects that are receiving a bone marrow transplant. As part of the transplant subjects will receive stem cells from a donor who has agreed to donate stem cells for them.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- TAR (NCT01611298)
- Testing
- Tetanus
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Robert Krance