Clinical trials: Delivery Systems
Asthma
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static…
- Trial name
- NCT01258803
- Testing
- Formoterol Fumarate DPI, Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer, Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
- Volunteers
- 92 people
- Sponsor
- Organon and Co
Parkinson's Disease
Study to Assess the Safety and Effects of Autologous Adipose-Derived SVF Cells in Patients With Parkinson's Disease
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.
- Trial name
- NCT01453803
- Testing
- Harvesting and Implantation of Adipose-Derived Stem Cells
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Asthma
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy…
- Trial name
- NCT01277523
- Testing
- tiotropium high dose, tiotropium low dose
- Where
- 69 sites in United States, Argentina and 12 more
- Volunteers
- 392 people
- Sponsor
- Boehringer Ingelheim
HNSCC, Melanoma
Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors
The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies.
- Conditions
- HNSCC, Melanoma, Gynecologic Cancer, Colorectal Cancer
- Trial name
- ACT (NCT05902520)
- Testing
- DP CD8 TIL, DP CD8 TIL KD, Low dose IL-2
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- AgonOx, Inc.
Limb-Girdle Muscular Dystrophy, Type 2E
Gene Delivery Clinical Trial of SRP-9003 (Bidridistrogene Xeboparvovec) for Participants With Limb-Girdle Muscular Dystrophy, Type 2E (LGMD2E) (Beta-Sarcoglycan Deficiency)
The proposed clinical trial is the first-in-human, single-center, open-label, gene delivery study of SRP-9003 (bidridistrogene xeboparvovec) in participants with LGMD2E.
- Trial name
- NCT03652259
- Testing
- SRP-9003
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sarepta Therapeutics, Inc.
Aortic Stenosis
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA…
- Trial name
- NCT03454360
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 10 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Symetis SA
Alzheimer's Disease
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
- Trial name
- NCT03432195
- Testing
- Donepezil TDS
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Corium, Inc.
Asthma
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \&…
- Trial name
- NCT01566149
- Testing
- Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI, Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
- Volunteers
- 49 people
- Sponsor
- Organon and Co
Exocrine Pancreatic Insufficiency
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.
- Trial name
- NCT00559052
- Testing
- VIOKASE 16
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Axcan Pharma
Pompe Disease, Pompe Disease (Late-onset)
A Gene Transfer Study for Late-Onset Pompe Disease (RESOLUTE)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT).
- Conditions
- Pompe Disease, Pompe Disease (Late-onset), Glycogen Storage Disease Type 2, Glycogen Storage Disease Type II
- Trial name
- NCT04093349
- Testing
- SPK-3006
- Where
- 29 sites in United States, Canada and 6 more
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Asthma
A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age.
- Trial name
- NCT02446418
- Testing
- Fluticasone Furoate, Vilanterol, Fluticasone propionate
- Where
- 93 sites in France, Germany
- Volunteers
- 423 people
- Sponsor
- GlaxoSmithKline
Healthy
A Device Study in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given.
- Trial name
- NCT04848402
- Testing
- On-Body Delivery System (OBDS)/Multiple Bolus Injector, Single Auto Injector
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Pancreatic Adenocarcinoma Non-resectable
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable.
- Trial name
- NCT07481383
- Testing
- ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Continuity Biosciences, LLC
GM1 Gangliosidosis, GM1 Gangliosidosis, Type I
Study of Safety, Tolerability and Efficacy of PBGM01 in Pediatric Participants With GM1 Gangliosidosis
PBGM01 is a gene therapy for GM1 gangliosidosis intended to deliver a functional copy of the GLB1 gene to the brain and peripheral tissues.
- Conditions
- GM1 Gangliosidosis, GM1 Gangliosidosis, Type I, GM1 Gangliosidosis, Type 2, Beta-Galactosidase-1 (GLB1) Deficiency
- Trial name
- Imagine-1 (NCT04713475)
- Testing
- PBGM01
- Where
- 7 sites in United States, Brazil and 2 more
- Volunteers
- 26 people
- Sponsor
- Gemma Biotherapeutics
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Wheezing, Reactive Airway Disease
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a…
- Conditions
- Wheezing, Reactive Airway Disease, Mild Asthma
- Trial name
- NCT03421730
- Testing
- VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Vectura Limited
Smoking, Tobacco
A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine…
- Trial name
- NCT07598136
- Testing
- P2613422, P2611222, P2615522
- Where
- 7 sites in United States
- Volunteers
- 1,280 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Motion Sickness
A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.
In this comparative bioavailability and in vivo skin adhesion study, the impact of minor changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and change of the manufacturing line of the micro…
- Trial name
- NCT02839135
- Testing
- Reformulated scopolamine patch, Marketed scopolamine patch
- Where
- Canada
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
SGA, Turner Syndrome, Noonan Syndrome, ISS
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature.
- Trial name
- REAL 8 (NCT05330325)
- Testing
- Somapacitan, Norditropin®
- Where
- 199 sites in United States, Austria and 31 more
- Volunteers
- 412 people
- Sponsor
- Novo Nordisk A/S
Asthma
A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug
Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor complex expressed on the eosinophil cell surface…
- Trial name
- NCT03014674
- Testing
- Lyophilized mepolizumab, Liquid mepolizumab, Prefilled autoinjector
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline