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Ipratropium

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

Ipratropium · 2 trials · 1 indication

Phase 1 2
NCT02207452Helium-3 MRI Imaging Study in COPDPulmonary Disease, Chronic Obstructive
COMPLETED11 Analytics
NCT00549120Optimising the Propranolol Block ModelPulmonary Disease, Chronic Obstructive
COMPLETED18 Analytics
PHASE1COMPLETED
Helium-3 MRI Imaging Study in COPD
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics
PHASE1COMPLETED
Optimising the Propranolol Block Model
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in Oxygen Saturation
Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.

To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.

Changes in distribution of regional ventilation/perfusion assessed by spatially registered Helium-3 Magnetic Resonance Imaging (MRI) and proton perfusion MRI.
Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.

To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.

Specific airway conductance (sGAW)
Pre-dose and up to 26 h post-dose

Secondary Endpoints

Changes in lung volumes.
Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Changes in standard lung function parameters.
Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
Number of adverse events
From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Salbutamol + IpratropiumOTHERTreatment period 1: Salbutamol 5mg nebulised, single Dose. Treatment period 2: Ipratropium 500mcg nebulised, single dose.
Ipratropium + SalbutamolOTHERTreatment period 1: Ipratropium 500mcg nebulised, single dose. Treatment period 2: Salbutamol 5mg nebulised, single Dose.
Propranolol aloneEXPERIMENTALPropranolol 80 mg (5 doses at 6 hourly intervals)
Propranolol + salbutamolEXPERIMENTALPropranolol 80 mg (5 doses at 6 hourly intervals) + salbutamol 600 μg (4 doses at 6 hourly intervals)
Salbutamol aloneEXPERIMENTALSalbutamol 600 μg (4 doses at 6 hourly) + placebo (5 doses at 6 hourly intervals)
PlaceboPLACEBO_COMPARATORPlacebo (5 doses at 6 hourly)
Propranolol + ipratropium + salbutamolEXPERIMENTALPropranolol 80 mg (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)
Placebo + ipratropium + salbutamolEXPERIMENTALPlacebo (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)

Interventions

NameTypeDescription
He-3 MRIDEVICEHyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
SalbutamolDRUGSalbutamol 5mg nebulised single dose
IpratropiumDRUGIpratropium 500mcg nebulised single dose
MRIDEVICEProton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
PropranololDRUG40 mg tablets
PlaceboDRUGPlacebo for propranolol tablets
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: \- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) diagnosis: an established clinical history of chronic pulmonary disorder in accordance with the following description by the American Thoracic Society / European Respiratory Society \[ATS / ETS, 2004\] Chronic obstruc...

Countries:United Kingdom
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