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Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years

NCT01883531 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2015-10-14

No results posted yet for this study

Summary

It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of trial treatment compared to treatment with inhaled placebo b.d.

Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a threshold of 3% for the purposes of determining an appropriate sample size for statistical power whilst retaining trial feasibility in an orphan disease population.

Conditions

Interventions

DRUG

Inhaled Mannitol

Active treatment is inhaled mannitol with a particle size of 3-4 microns

DRUG

Inhaled Placebo

The PLacebo is non respirable mannitol due to the big size particle

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Christiane De Boeck · UZ Leuven, Belgium

  • Jeremy Hull, Dr · John Radcliffe Hospital, Oxford, UK

  • Anne Munck, Dr · Hôpital Robert Debré, France

  • Joachim Riethmuller, Dr · Universitats Kinderklinik Tubingen, Germany

  • Larry Lands, MD · 'Montreal Children's Hospital, Montreal, Canada

  • Alexander Möller, MD · University Childrens Hospital Zurich

  • Sonia Volpi, MD · Azienda Ospedaliera Universitaria Integrata Verona Italy

  • Harm Tiddens, MD · Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT01883531 on ClinicalTrials.gov