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Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

NCT01194700 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-04-12

No results posted yet for this study

Summary

The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.

Conditions

Interventions

DRUG

Seretide 250(8puffs) via Evohaler actuator

8 puffs of Seretide250/Placebo via Evohaler actuator

DRUG

Seretide 250 (8 puffs)/placebo via Volumatic spacer

8 puffs of Seretide 250/placebo via volumatic spacer

DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus

DRUG

Seretide 250/placebo via Synchro-Breathe

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Sponsors & Collaborators

  • Brian J Lipworth

    lead OTHER

Principal Investigators

  • Arun Nair · University of Dundee

  • Brian J Lipworth · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01194700 on ClinicalTrials.gov