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Profiling

Phase 1

Pulmonary Disease, Chronic Obstructive | Unknown | Other |GSK plc|Last Updated: Jun 22, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01345266Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung MorphometryPHASE1 COMPLETED 106Feb 1, 2010Jun 28, 2010Jun 22, 20172 Belgium
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Study Endpoints
Primary Endpoints
Inhaltion Profile Recording (IPR): Measures will be Peak Pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s) Average Inhalation flow rate (L/min)
24 hours

To characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe asthma and volunteers with mild, moderate and severe COPD, through the novel DPI, using the IPR

Pharangometry: Measures will be, Distance (cm) Volume (cm3) Average cross sectional area (cm2)
24 hours

To characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe asthma and volunteers with mild, moderate and severe COPD, using pharangometry

Secondary Endpoints
HRCT scans: Measures are Total Lung Capacity (TLC) and Functional Residual capacity (FRC)
24 hours
Lung function indices by spirometry: Measures, FEV1, Vmax25 and 50, PEFR, PIFR
24 hours
Whole body plethysmography: Measures include.Volume: total lung, residual volume, functional reserve volume, Impedance - generation 0 to 6, Resistance - generation 0 to 6 and Diffusion.
24 hours
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Inhalation ProfilingOTHERAll subjects have Inhaltion profiling, there are no other arms.
Interventions
NameTypeDescription
Inhalation ProfilingPROCEDUREAll subects recieve Inhaltion Profiling there are no interventions.
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply. * All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent. * All female volunteers of child bearing potential must h...

Countries:Belgium
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