Clinical trials: Care Delivery
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 I)
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
- NCT00772538
- Testing
- tiotropium 5mcg/day
- Where
- 73 sites in United States, Australia and 12 more
- Volunteers
- 459 people
- Sponsor
- Boehringer Ingelheim
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
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
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Chronic Myocardial Ischemia, Refractory Angina Pectoris
Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and…
- Conditions
- Chronic Myocardial Ischemia, Refractory Angina Pectoris, Advanced Coronary Heart Disease
- Trial name
- RENEW (NCT01508910)
- Testing
- Auto-CD34+ cells, Standard of care
- Where
- 41 sites in United States
- Volunteers
- 291 people
- Sponsor
- Lisata Therapeutics, Inc.
Sedation
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU)…
- Trial name
- INSPiRE-ICU2 (NCT05327296)
- Testing
- Isoflurane, Propofol
- Where
- 16 sites in United States
- Volunteers
- 282 people
- Sponsor
- Sedana Medical
Colonoscopy, Endoscopy, Digestive System
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures.
- Conditions
- Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
- Trial name
- NCT00452426
- Testing
- Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Ethicon Endo-Surgery
Venous Thromboembolism
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate…
- Trial name
- NCT01895777
- Testing
- dabigatran etexilate, standard of care
- Where
- 65 sites in United States, Argentina and 24 more
- Volunteers
- 267 people
- Sponsor
- Boehringer Ingelheim
Sensorineural Hearing Loss, Bilateral
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Trial name
- NCT03904420
- Testing
- Clinical Education and Treatment Model, Traditional Model
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Cochlear
Premature Infants
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study.
- Trial name
- NCT01077271
- Where
- 45 sites in Austria
- Volunteers
- 124 people
- Sponsor
- Abbott
Hepatitis C
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with…
- Trial name
- COPE-HCV (NCT00919633)
- Testing
- interferon alfa-2b, peginterferon alfa-2b, ribavirin, USP
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
Diabetes Type 2
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.
- Trial name
- CLOSEAP+ (NCT04233229)
- Testing
- t:slim X2 with Control-IQ, home healthcare services, usual care for daily insulin treatment
- Where
- 10 sites in France
- Volunteers
- 43 people
- Sponsor
- Air Liquide Santé International
Asthma
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on…
- Trial name
- NCT01634152
- Testing
- Tiotropium low dose mcg, Tiotropium high dose
- Where
- 94 sites in United States, Argentina and 15 more
- Volunteers
- 401 people
- Sponsor
- Boehringer Ingelheim
Sedation
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU)…
- Trial name
- INSPiRE-ICU1 (NCT05312385)
- Testing
- Isoflurane, Propofol, Isoflurane (run-ins)
- Where
- 14 sites in United States
- Volunteers
- 277 people
- Sponsor
- Sedana Medical
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol…
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Trial name
- SPIRIT (NCT04807400)
- Testing
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- Where
- 17 sites in United Kingdom
- Volunteers
- 892 people
- Sponsor
- Novartis Pharmaceuticals
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