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Profiling

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

Profiling · 1 trial · 1 indication

Phase 1 1
NCT01345266Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung MorphometryPulmonary Disease, Chronic Obstructive
COMPLETED106 Analytics
PHASE1COMPLETED
Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

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 to 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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Frequently asked questions about Profiling

What is Profiling used for in Pulmonary Disease, Chronic Obstructive?

Profiling is an investigational drug being studied for use in chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development. The drug is being developed by GSK plc (GSK) as a potential treatment for respiratory conditions.

Who makes Profiling?

Profiling is being developed by GSK plc, a global biopharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's potential in treating chronic obstructive pulmonary disease.

What phase is Profiling in?

Profiling is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating chronic obstructive pulmonary disease.

What clinical trials is Profiling in?

Profiling has one completed clinical trial registered under NCT01345266. This Phase 1 study, titled 'Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry,' enrolled 106 participants in Belgium.

Is Profiling the same as any other drug?

Profiling is the name used for this investigational drug in clinical development. No alternative names have been reported for this asset. It is being studied specifically for its potential application in chronic obstructive pulmonary disease.