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A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects

NCT02134353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2020-10-28

Study results available
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Summary

This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above.

We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population

Conditions

Interventions

DRUG

Inhaled mannitol

Inhaled mannitol 400 mg BD for 26 weeks

DRUG

Placebo Comparator: Arm B - Control

Placebo Comparator: Arm B - Control BD for 26 weeks

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Moira Aitken, MD

  • Brett Charlton, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Hungary
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

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 NCT02134353 on ClinicalTrials.gov