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The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

NCT01662778 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-11-18

Study results available
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Summary

The objective here is to determine that the efficiency of inhaled drug delivery can be improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of drug particles). This information will be valuable in designing new inhalers in order to improve their beneficial effects and reduce their side effects, by using the least possible drug dose to achieve a good patient response.

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Conditions

Interventions

DRUG

1.5 microns at 50mg

STAG generated monodisperse 1.5micron particles

DRUG

6 microns at 50mg

STAG generated monodisperse 6 micron particles

DRUG

Placebo Comparator

No drug just solvent

DRUG

MDI FP

Sponsors & Collaborators

Principal Investigators

  • Omar Usmani, MBBS · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662778 on ClinicalTrials.gov