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Clinical trialNCT02134353CompletedPhase 3Interventional

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

SponsorSyntaraEnrollment423Cystic Fibrosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

100 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Insares

    Mendoza, Mendoza Province, Argentina

  • Hospital Interzonal General de Agudos Dr. Jose Penna

    Bahía Blanca, Argentina

  • Hospital Regional Español de Bahía Blanca

    Buenos Aires, Argentina

  • Hospital del Tórax Cetrángolo

    Buenos Aires, Argentina

  • Hospital San Roque

    Córdoba, Argentina

Australia
  • Mater Adult Hospital

    Brisbane, Queensland, Australia

Belgium
  • Uz Vub

    Brussels, Belgium

  • Uz Leuven

    Leuven, Belgium

  • Chr Citadelle

    Liège, Belgium

Canada
  • Qeii Health Sciences Center

    Halifax, Canada

  • Institut de Recherches Cliniques de Montréal

    Montreal, Canada

  • the Ottawa Hospital, General Campus

    Ottawa, Canada

Czechia
  • Fn Brno

    Brno, Czechia

Hungary
  • Országos Korányi Tbc

    Budapest, Hungary

  • Klinikai Farmakológiai Központ

    Debrecen, Hungary

  • Mosdós Tüdőgyógyintézet

    Mosdós, Hungary

  • Törökbálint Tüdőgyógyintézet

    Törökbálint, Hungary

Israel
  • Pediatrics Pulmonary Department Rambam Healthcare Campus

    Haifa, Israel

  • Schneider Children'S Medical Center of Israel

    Petah Tikva, Israel

Italy
  • Spedali Civili Brescia

    Brescia, Italy

  • Irccs Ca' Granda Ospedale Maggiore Policlinico Mil

    Milan, Italy

  • Aou San Luigi Gonzaga

    Orbassano, Italy

  • Aziendao Spedaliera Universitaria

    Parma, Italy

  • Cystic Fibrosis Center Hospital San Carlo

    Potenza, Italy

  • Centro Fibrosi Cistica Policlinico Umberto I

    Roma, Italy

  • Azienda Ospedaliera Universitaria Integratadi Verona

    Verona, Italy

Mexico
  • Instituto Jaliscience de Investigacion Clinica

    Guadalajara, Mexico

  • Unidad Médica de Occidente

    Guadalajara, Mexico

  • Arke Estudios Clinicos S.A

    Mexico City, Mexico

  • Ceprep- Hospital Universitario

    Monterrey, Mexico

New Zealand
  • Greenlane Hospital

    Auckland, New Zealand

  • Canterbury Respiratory Research Group

    Christchurch, New Zealand

  • Otago Respiratory Research Unit, Dunedin Hospital

    Dunedin, New Zealand

Poland
  • Szpital Dziecięcy Polanki Im. M. Płażyńskiego W Gdańsku Sp.

    Gdansk, Poland

  • Centrum Medyczne Karpacz Sa

    Karpacz, Poland

  • Wojewodzki Specjalistyczny Szpital Dzieciecy Im. W. Buszkowskiego

    Kielce, Poland

  • Wojewodzki Szpital Specjalistyczny Im.

    Lodz, Poland

  • Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu

    Poznan, Poland

  • Sanatorium Cassia-Villa Medica S.C.

    Rabka-Zdrój, Poland

  • Podkarpacki Osrodek Pulmonologii I Alergologii

    Rzeszów, Poland

60 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Inhaled mannitolPlacebo Comparator: Arm B - Control
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2014
Primary completion
28 Feb 2017
Completion
28 Feb 2017
Last update posted
28 Oct 2020
Registered enrollment
423
Registry id
NCT02134353
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.