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Ipratropium

Phase 4

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

Ipratropium development status

Highest phase Phase 4 run by GlaxoSmithKline (NCT01691482)
Phase scored for MRKPhase 2
Registered trials 4 across 2 sponsors since Oct 2007

Ipratropium target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Ipratropium clinical trials

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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Frequently asked questions about Ipratropium

What is ipratropium used for in chronic obstructive pulmonary disease?

Ipratropium is a small molecule developed by Merck & Company, Inc. (ticker MRK) for chronic obstructive pulmonary disease, a respiratory condition. It is being studied in clinical development for COPD, and the program includes a completed Phase 2 trial conducted in the United Kingdom in adults aged 40 years and older.

What does ipratropium target?

Ipratropium targets CHRM3, the M3 muscarinic acetylcholine receptor. It acts as an antagonist at this receptor, meaning it blocks receptor signaling. This target class places ipratropium among antimuscarinic agents, a mechanism relevant to airway smooth muscle control in chronic obstructive pulmonary disease.

Who makes ipratropium?

Ipratropium is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor associated with the clinical development program for this small molecule in chronic obstructive pulmonary disease, a respiratory therapeutic area.

What phase is ipratropium in?

Ipratropium is in Phase 2 clinical development for chronic obstructive pulmonary disease. It is an investigational small molecule and is not described as approved. The development program includes one completed Phase 2 trial, and no active trials are currently listed for this asset.

What clinical trials is ipratropium in?

Ipratropium has been evaluated in the completed Phase 2 trial NCT02542254, titled The Effects of RPL554 on Top of Standard COPD Reliever Medications. That trial enrolled 36 participants with chronic obstructive pulmonary disease in the United Kingdom, was randomized, double blind, and placebo controlled, and included adults aged 40 years and older.