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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inhaled mannitol
Placebo Comparator: Arm B - Control
Sponsored by
Pharmaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have given written informed consent to participate in this trial in accordance with local regulations;
  2. Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype);
  3. Be aged at least 18 years old;
  4. Have FEV1 > 40 % and < 90% predicted (using NHanes III [1]);
  5. Be able to perform all the techniques necessary to measure lung function;
  6. Be adherent with maintenance therapies (antibiotics and or rhDNase), if used, for at least 80% of the time in the two weeks prior to visit 1 and
  7. If rhDNase and/or maintenance antibiotic are being used treatment must have been established at least 1 month prior to screening (Visit 0). The subject should remain on the rhDNase and / or maintenance antibiotics for the duration of the trial. The subject should not commence treatment with rhDNase or maintenance antibiotics during the trial

Exclusion Criteria:

  1. Be investigators, site personnel directly affiliated with this trial, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted;
  2. Be considered "terminally ill" or eligible for lung transplantation;
  3. Have had a lung transplant;
  4. Be using maintenance nebulized hypertonic saline in the 2 weeks prior to visit 1;
  5. Have had a significant episode of hemoptysis (> 60 mL) in the three months prior to Visit 0;
  6. Have had a myocardial infarction in the three months prior to Visit 0;
  7. Have had a cerebral vascular accident in the three months prior to Visit 0;
  8. Have had major ocular surgery in the three months prior to Visit 0;
  9. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0;
  10. Have a known cerebral, aortic or abdominal aneurysm;
  11. Be breast feeding or pregnant, or plan to become pregnant while in the trial;
  12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only);
  13. Be participating in another investigative drug trial, parallel to, or within 4 weeks of screening (Visit 0);
  14. Have a known allergy to mannitol;
  15. Be using non-selective oral beta blockers;
  16. Have uncontrolled hypertension -i.e. systolic BP > 190 and / or diastolic BP > 100;
  17. Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the subject's participation in the trial;or
  18. Have a failed or incomplete MTT at trial entry (as evaluated in Section 8.1.1.1).
  19. The subject must not commence treatment with rhDNase or maintenance antibiotics during the trial.

Sites / Locations

  • Dr Lawrence Sinde
  • University of Arizona
  • University of Arkansas for Medical Sciences
  • Pediatric Pulmonology
  • University of CA, Davis
  • Hartford Hospital
  • Dr Mitchell Rothstein
  • University of Miami
  • Central Florida Pulmonary Group, P.A.
  • Tampa General Hospital
  • Cystic Fibrosis Center of Chicago
  • Loyola University Medical Center
  • Illinois Lung Institute
  • University of Kansas Hospital
  • Kosair Charities Pediatric Clinical Research Unit
  • John Hopkins
  • Massachusetts General Hospital
  • Spectrum Health Offices of Research Administration
  • University of Minnesota
  • University of Mississippi Medical Center
  • Dr Joseph Ojile
  • Dartmouth-Hitchcock Specialty Care
  • Long Island Jewish Medical Center
  • The Cystic Fibrosis Center Beth Israel Medical Center
  • Dr Allen Dozor
  • Akron Children's Hospital
  • University of Cincinnati
  • Nationwide Children's Hospital
  • The Children's Medical Center of Dayton
  • The Toledo Hospital and Toledo Childrens Hospital
  • Pediatric Pulmonary & CF Center
  • Dr Santiago Reyes
  • Pediatric Clinic
  • Medical University of SC
  • One Richland Medical Park
  • University of Washington
  • Insares
  • Hospital Interzonal General de Agudos Dr. Jose Penna
  • Hospital del Tórax Cetrángolo
  • Hospital Regional Español de Bahía Blanca
  • Hospital San Roque
  • Mater Adult Hospital
  • UZ VUB
  • UZ Leuven
  • CHR Citadelle
  • QEII Health Sciences Center
  • Institut de recherches cliniques de Montréal
  • The Ottawa Hospital, General Campus
  • FN Brno
  • Országos Korányi Tbc
  • Klinikai Farmakológiai Központ
  • Mosdós Tüdőgyógyintézet
  • Törökbálint Tüdőgyógyintézet
  • Pediatrics Pulmonary Department Rambam Healthcare Campus
  • Schneider Children's Medical Center of Israel
  • Spedali Civili Brescia
  • IRCCS Ca' Granda Ospedale Maggiore Policlinico Mil
  • AOU San Luigi Gonzaga
  • Aziendao Spedaliera Universitaria
  • Cystic Fibrosis Center Hospital San Carlo
  • Centro Fibrosi Cistica Policlinico Umberto I
  • Azienda Ospedaliera Universitaria Integratadi Verona
  • Instituto Jaliscience de Investigacion Clinica
  • Unidad Médica de Occidente
  • Arke Estudios Clinicos S.A
  • CEPREP- Hospital Universitario
  • Greenlane Hospital
  • Canterbury Respiratory Research Group
  • Otago Respiratory Research Unit, Dunedin Hospital
  • Szpital Dziecięcy Polanki im. M. Płażyńskiego w Gdańsku sp.
  • Centrum Medyczne Karpacz SA
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. W. Buszkowskiego
  • Wojewodzki Szpital Specjalistyczny im.
  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
  • Sanatorium Cassia-Villa Medica S.C.
  • Podkarpacki Osrodek Pulmonologii i Alergologii
  • Institutul pentru Ocrotirea Mamei si Copilului "Alfred Rusescu"
  • Institutul de Pneumoftiziologie "Marius Nasta" Bucuresti, Sectia Clinica Pneumologie V
  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
  • Spitalul Clinic de Pneumoftiziologie Lasi
  • Tatiana I. Martynenko
  • Pulmonology Research Institute
  • Research and Clinical Center of interstitial and orphan lung diseases
  • Mikhail Smirnov
  • Clinical Hospital# 2
  • Oddelenie pneumológie a ftizeológie
  • Imuno-alergologická ambulancia
  • Detská fakultná nemocnica Košice
  • University of Cape Town Lung Institute
  • St. Augustine's Medical Centre 2
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitaro La Paz
  • Hospital Universitario Central de Asturias
  • Hospital Virgen del Rocio Hospital Unidad de Fibrosis Quistica
  • Hospital Universitario La Fe Neumología
  • Dnipropetrovsk State Medical Academy, Faculty Theraphy and Endocrinology Chair
  • Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olha Tropin
  • Kremenchuk First City Hospital n.a. O.T.Bogaevskyy
  • Department of Pulmonology and Thoracic Surgery of Public Institution " Kryvyy Rig City Clinical Hospital # 8
  • Hospital Department of Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental arm A

Arm B - Control

Arm Description

Active treatment. Inhaled Mannitol

Arm B

Outcomes

Primary Outcome Measures

Mean Change in FEV1 (mL) From Baseline (Visit 1) Over the 26-week Treatment Period (to Visit 4).
The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).

Secondary Outcome Measures

Mean Change From Baseline FVC (mL) Over the 26-week Treatment Period
To determine whether inhaled mannitol (400 mg b.i.d.) is superior to control for improving lung function as measured by mean change from baseline forced vital capacity (FVC) (mL) over the 26-week treatment period in adult subjects with cystic fibrosis (CF). The mean absolute change from baseline FVC (mL) over 26 weeks will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).

Full Information

First Posted
April 16, 2014
Last Updated
October 6, 2020
Sponsor
Pharmaxis
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1. Study Identification

Unique Protocol Identification Number
NCT02134353
Brief Title
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Official Title
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaxis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
This is a double-blind, randomized, parallel arm, controlled, multicenter, and interventional clinical trial. Potential subjects will sign the informed consent form (ICF) and be assessed for eligibility. After satisfying all inclusion & exclusion criteria, subjects will be given a mannitol tolerance test (MTT). Those subjects that pass the MTT will be randomized to receive inhaled mannitol (400 mg b.i.d.) or control b.i.d. for a period of 26-weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm A
Arm Type
Experimental
Arm Description
Active treatment. Inhaled Mannitol
Arm Title
Arm B - Control
Arm Type
Placebo Comparator
Arm Description
Arm B
Intervention Type
Drug
Intervention Name(s)
Inhaled mannitol
Intervention Description
Inhaled mannitol 400 mg BD for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: Arm B - Control
Intervention Description
Placebo Comparator: Arm B - Control BD for 26 weeks
Primary Outcome Measure Information:
Title
Mean Change in FEV1 (mL) From Baseline (Visit 1) Over the 26-week Treatment Period (to Visit 4).
Description
The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline FVC (mL) Over the 26-week Treatment Period
Description
To determine whether inhaled mannitol (400 mg b.i.d.) is superior to control for improving lung function as measured by mean change from baseline forced vital capacity (FVC) (mL) over the 26-week treatment period in adult subjects with cystic fibrosis (CF). The mean absolute change from baseline FVC (mL) over 26 weeks will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Time to First Pulmonary Exacerbation Over the 26-week Treatment Period
Description
To determine whether inhaled mannitol (400 mg b.i.d.) is superior to control in increasing the time to first protocol defined pulmonary exacerbation over the 26-week treatment period in adult subjects with CF. Protocol defined pulmonary exacerbations are those where 4 or more symptoms are recorded and are treated with IV antibiotics
Time Frame
26 weeks
Title
Number of Days on Antibiotics (Oral, Inhaled or IV) Due to Pulmonary Exacerbation
Description
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing the number of days on antibiotics due to protocol defined pulmonary exacerbations. Overlapping antibiotics are counted separately.
Time Frame
26 weeks
Title
Number of Days in Hospital Due to Pulmonary Exacerbation
Description
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing the number of days in hospital due to protocol defined pulmonary exacerbation.
Time Frame
26 weeks
Title
Rate of Pulmonary Exacerbations Over the 26-week Treatment Period
Description
To determine whether inhaled mannitol (400 mg b.i.d.) decreases the rate of protocol defined pulmonary exacerbations over the 26-week treatment period compared to control in adult subjects with CF. Protocol defined pulmonary exacerbations defined by having 4 or more symptoms and treated with IV antibiotics.
Time Frame
26 weeks
Title
The Incidence of Pulmonary Exacerbations
Description
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing incidence of protocol defined pulmonary exacerbations, where incidence is defined as the proportion of subjects with 1 or more exacerbation during the 26 week period.
Time Frame
26 weeks
Title
Mean Change From Baseline in Ease of Expectoration Measured Using a Visual Analogue Scale (VAS) Over 26 Weeks
Description
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for improving ease of expectoration. The visual analogue scale (VAS) was 10cm. The position marked by the subject was converted into a score from 0 to 100 where 0 was the worst possible outcome and 100 was the best possible outcome. The VAS was completed at baseline, 6, 14 and 26 weeks. The mean absolute change from baseline over 26 weeks (ie the average of the changes at 6,14 and 26 weeks) is the outcome measure and will be compared between the two treatment groups with a REML based repeated measures approach. Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Time Frame
26 weeks
Title
Change From Baseline Over 26 Weeks in CFQ-R Respiratory Domain Score
Description
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for improving respiratory symptoms measured by Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain. The CFQ-R respiratory domain score is a scale from 0 to 100. Higher scores are a more favourable response. The mean absolute change from baseline over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have given written informed consent to participate in this trial in accordance with local regulations; Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype); Be aged at least 18 years old; Have FEV1 > 40 % and < 90% predicted (using NHanes III [1]); Be able to perform all the techniques necessary to measure lung function; Be adherent with maintenance therapies (antibiotics and or rhDNase), if used, for at least 80% of the time in the two weeks prior to visit 1 and If rhDNase and/or maintenance antibiotic are being used treatment must have been established at least 1 month prior to screening (Visit 0). The subject should remain on the rhDNase and / or maintenance antibiotics for the duration of the trial. The subject should not commence treatment with rhDNase or maintenance antibiotics during the trial Exclusion Criteria: Be investigators, site personnel directly affiliated with this trial, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted; Be considered "terminally ill" or eligible for lung transplantation; Have had a lung transplant; Be using maintenance nebulized hypertonic saline in the 2 weeks prior to visit 1; Have had a significant episode of hemoptysis (> 60 mL) in the three months prior to Visit 0; Have had a myocardial infarction in the three months prior to Visit 0; Have had a cerebral vascular accident in the three months prior to Visit 0; Have had major ocular surgery in the three months prior to Visit 0; Have had major abdominal, chest or brain surgery in the three months prior to Visit 0; Have a known cerebral, aortic or abdominal aneurysm; Be breast feeding or pregnant, or plan to become pregnant while in the trial; Be using an unreliable form of contraception (female subjects at risk of pregnancy only); Be participating in another investigative drug trial, parallel to, or within 4 weeks of screening (Visit 0); Have a known allergy to mannitol; Be using non-selective oral beta blockers; Have uncontrolled hypertension -i.e. systolic BP > 190 and / or diastolic BP > 100; Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the subject's participation in the trial;or Have a failed or incomplete MTT at trial entry (as evaluated in Section 8.1.1.1). The subject must not commence treatment with rhDNase or maintenance antibiotics during the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moira Aitken, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brett Charlton, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Dr Lawrence Sinde
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pediatric Pulmonology
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
University of CA, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Dr Mitchell Rothstein
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Central Florida Pulmonary Group, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cystic Fibrosis Center of Chicago
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Illinois Lung Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61537
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64081
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
62114
Country
United States
Facility Name
Spectrum Health Offices of Research Administration
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Dr Joseph Ojile
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Dartmouth-Hitchcock Specialty Care
City
Bedford
State/Province
New Hampshire
ZIP/Postal Code
03110
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The Cystic Fibrosis Center Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Dr Allen Dozor
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0564
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Children's Medical Center of Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
The Toledo Hospital and Toledo Childrens Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Pediatric Pulmonary & CF Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Dr Santiago Reyes
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Pediatric Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Medical University of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
One Richland Medical Park
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Insares
City
Mendoza
State/Province
Provincia De Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Hospital Interzonal General de Agudos Dr. Jose Penna
City
Bahia Blanca
ZIP/Postal Code
2401 (8001)
Country
Argentina
Facility Name
Hospital del Tórax Cetrángolo
City
Buenos Aires
ZIP/Postal Code
1750
Country
Argentina
Facility Name
Hospital Regional Español de Bahía Blanca
City
Buenos Aires
ZIP/Postal Code
8000
Country
Argentina
Facility Name
Hospital San Roque
City
Cordoba
ZIP/Postal Code
1900 (5000)
Country
Argentina
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
UZ VUB
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHR Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
QEII Health Sciences Center
City
Halifax
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
ZIP/Postal Code
H2X 2L0
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
FN Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Országos Korányi Tbc
City
Budapest
ZIP/Postal Code
H-1125
Country
Hungary
Facility Name
Klinikai Farmakológiai Központ
City
Debrecen
ZIP/Postal Code
H-1031
Country
Hungary
Facility Name
Mosdós Tüdőgyógyintézet
City
Mosdós
ZIP/Postal Code
H-7257
Country
Hungary
Facility Name
Törökbálint Tüdőgyógyintézet
City
Törökbálint
ZIP/Postal Code
H-2045
Country
Hungary
Facility Name
Pediatrics Pulmonary Department Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Spedali Civili Brescia
City
Brescia
Country
Italy
Facility Name
IRCCS Ca' Granda Ospedale Maggiore Policlinico Mil
City
Milano
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Orbassano
Country
Italy
Facility Name
Aziendao Spedaliera Universitaria
City
Parma
Country
Italy
Facility Name
Cystic Fibrosis Center Hospital San Carlo
City
Potenza
Country
Italy
Facility Name
Centro Fibrosi Cistica Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integratadi Verona
City
Verona
Country
Italy
Facility Name
Instituto Jaliscience de Investigacion Clinica
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Unidad Médica de Occidente
City
Guadalajara
ZIP/Postal Code
44220
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A
City
Mexico City
ZIP/Postal Code
CP 6700
Country
Mexico
Facility Name
CEPREP- Hospital Universitario
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Greenlane Hospital
City
Auckland
Country
New Zealand
Facility Name
Canterbury Respiratory Research Group
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Otago Respiratory Research Unit, Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Szpital Dziecięcy Polanki im. M. Płażyńskiego w Gdańsku sp.
City
Gdańsk
ZIP/Postal Code
80-308
Country
Poland
Facility Name
Centrum Medyczne Karpacz SA
City
Karpacz
ZIP/Postal Code
58-540
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. W. Buszkowskiego
City
Kielce
ZIP/Postal Code
25-381
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im.
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Sanatorium Cassia-Villa Medica S.C.
City
Rabka Zdroj
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Podkarpacki Osrodek Pulmonologii i Alergologii
City
Rzeszow
ZIP/Postal Code
35-612
Country
Poland
Facility Name
Institutul pentru Ocrotirea Mamei si Copilului "Alfred Rusescu"
City
Bucuresti
ZIP/Postal Code
020395
Country
Romania
Facility Name
Institutul de Pneumoftiziologie "Marius Nasta" Bucuresti, Sectia Clinica Pneumologie V
City
Bucuresti
ZIP/Postal Code
050159
Country
Romania
Facility Name
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
City
Cluj - Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Spitalul Clinic de Pneumoftiziologie Lasi
City
Lasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
Tatiana I. Martynenko
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Pulmonology Research Institute
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Research and Clinical Center of interstitial and orphan lung diseases
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Mikhail Smirnov
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Clinical Hospital# 2
City
Yaroslavl
ZIP/Postal Code
150010
Country
Russian Federation
Facility Name
Oddelenie pneumológie a ftizeológie
City
Banská Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Imuno-alergologická ambulancia
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
Facility Name
Detská fakultná nemocnica Košice
City
Košice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
University of Cape Town Lung Institute
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
St. Augustine's Medical Centre 2
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
Country
Spain
Facility Name
Hospital Universitaro La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Virgen del Rocio Hospital Unidad de Fibrosis Quistica
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario La Fe Neumología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Dnipropetrovsk State Medical Academy, Faculty Theraphy and Endocrinology Chair
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olha Tropin
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kremenchuk First City Hospital n.a. O.T.Bogaevskyy
City
Kremenchuk
ZIP/Postal Code
396170
Country
Ukraine
Facility Name
Department of Pulmonology and Thoracic Surgery of Public Institution " Kryvyy Rig City Clinical Hospital # 8
City
Kryvyy Rig
ZIP/Postal Code
50047
Country
Ukraine
Facility Name
Hospital Department of Municipal Institution "Zaporizhzhya Regional Clinical Hospital"
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
33715994
Citation
Flume PA, Amelina E, Daines CL, Charlton B, Leadbetter J, Guasconi A, Aitken ML. Efficacy and safety of inhaled dry-powder mannitol in adults with cystic fibrosis: An international, randomized controlled study. J Cyst Fibros. 2021 Nov;20(6):1003-1009. doi: 10.1016/j.jcf.2021.02.011. Epub 2021 Mar 11.
Results Reference
derived

Learn more about this trial

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

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