Clinical trials: Delivery Systems
Asthma
A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma
The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.
- Trial name
- COMPAIR (NCT07433569)
- Testing
- Budesonide/formoterol fumarate Aerosphere, Budesonide/formoterol fumarate pMDI
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Asthma
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved…
- Trial name
- NCT06502366
- Testing
- BDA MDI HFO 160/180 μg, BDA MDI HFA 160/180 μg
- Where
- 128 sites in United States, China and 4 more
- Volunteers
- 424 people
- Sponsor
- AstraZeneca
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Parkinson's Disease
A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant…
- Trial name
- NCT02096601
- Testing
- LD/CD SC solution, Entacapone
- Where
- 2 sites in Israel
- Volunteers
- 16 people
- Sponsor
- NeuroDerm Ltd.
Major Depressive Disorder (MDD)
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS.
- Trial name
- NCT07452692
- Testing
- Selegiline Transdermal Delivery System
- Where
- 3 sites in Bulgaria
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Asthma, Healthy Subjects or Volunteers
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
- Trial name
- NCT02085473
- Testing
- Tralokinumab 300 mg
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Hepatitis B
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule
Hepatitis B virus (HBV) infection is an important global health problem, and the WHO adopted a strategy to eliminate HBV infection as a public health threat by the year 2030.
- Trial name
- NEOVAC2BK (NCT04029454)
- Testing
- birth dose vaccination against hepatitis B strategy
- Where
- 2 sites in Burkina Faso
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hepatocellular Carcinoma
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick," to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon.
- Trial name
- NCT00054951
- Testing
- MTC-DOX for Injection
- Where
- 3 sites in China
- Volunteers
- 30 people
- Sponsor
- FeRx
Open Surgery, Lymphedema
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.
- Conditions
- Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery
- Trial name
- PRECISE (NCT06725030)
- Testing
- Symani Surgical System
- Where
- 6 sites in United States
- Volunteers
- 455 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Asthma
Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma.
- Trial name
- NCT00467740
- Testing
- BI 1744 CL
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- Boehringer Ingelheim
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
HIV Infections
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active…
- Trial name
- NCT00469170
- Testing
- intravaginal ring
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix
Asthma
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once…
- Trial name
- NCT01122680
- Testing
- Tiotropium bromide
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 105 people
- Sponsor
- Boehringer Ingelheim
Contraception
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- NCT01181479
- Testing
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- Where
- 80 sites in United States
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Cystic Fibrosis
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic…
- Trial name
- NCT04059094
- Testing
- BI 1265162
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
Asthma
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years…
- Trial name
- NCT00746330
- Testing
- Mometasone furoate/formoterol fumarate (MFF), Formoterol fumarate 12 μg pMDI (F12M), Formoterol fumarate 12 μg DPI (F12D)
- Where
- 9 sites in United States, Colombia and 1 more
- Volunteers
- 32 people
- Sponsor
- Novartis
Relapsing Remitting Multiple Sclerosis (RRMS)
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.
- Trial name
- TOFIINGO (NCT01499667)
- Testing
- Fingolimod
- Where
- 44 sites in Australia, Austria and 9 more
- Volunteers
- 142 people
- Sponsor
- Novartis Pharmaceuticals