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Ipratropium

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Sep 9, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Ipratropium · 1 trial · 1 indication

Phase 2 1
NCT02542254The Effects of RPL554 on Top of Standard COPD Reliever MedicationsChronic Obstructive Pulmonary Disease
COMPLETED36 Analytics
PHASE2COMPLETED
The Effects of RPL554 on Top of Standard COPD Reliever Medications
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

8 hour spirometry
8 hours

Forced expired volume in one second (FEV1) over 8 hours post-dose

Secondary Endpoints

12 hour spirometry
12 hours
Whole body plethysmography
4 hours
Area under the curve (AUC)
12 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Salbutamol aloneACTIVE_COMPARATOR200 micrograms salbutamol, ipratropium matched placebo and RPL554 matched placebo
Salbutamol and RPL554EXPERIMENTAL200 micrograms salbutamol, ipratropium matched placebo and 6 mg RPL554
IpratropiumACTIVE_COMPARATORSalbutamol matched placebo, 40 micrograms ipratropium and RPL554 matched placebo
Ipratropium and RPL554EXPERIMENTALSalbutamol matched placebo, 40 micrograms ipratropium and 6 mg RPL554
RPL554EXPERIMENTALSalbutamol matched placebo, ipratropium matched placebo and 6 mg RPL554
PlaceboPLACEBO_COMPARATORSalbutamol matched placebo, ipratropium matched placebo and RPL554 matched placebo

Interventions

NameTypeDescription
SalbutamolDRUG200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI)
IpratropiumDRUG40 micrograms ipratropium administered using a pMDI
RPL554DRUG6 mg RPL554 administered using a nebuliser
Salbutamol matched placeboDRUGPlacebo pMDI
Ipratropium matched placeboDRUGPlacebo pMDI
RPL554 matched placeboDRUGNebulised placebo
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Eligibility Criteria

Age Range40 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provide informed consent * Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal * 12-lead ECG showing:Heart rate 45 to 90 bpm, QTcF≤450 msec, QRS ≤120 msec, PR interval ≤220 msec, no clinically significant abnormalit...

Countries:United Kingdom
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