Cystic FibrosisPhase 3NCT00630812
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
A Phase 3 study testing inhaled mannitol in people with Cystic Fibrosis, run by Syntara at 53 sites in 7 countries.
Trial summary
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- inhaled mannitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 53 sitesin 7 countries
- Study dates
- Sep 2008to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have given written informed consent to participate in this study 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 > 6 years old
- Have FEV1 >40 % and < 90% predicted
- Be able to perform all the techniques necessary to measure lung function
Who cannot join
- Investigators, site personnel directly affiliated with this study, 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 nebulized hypertonic saline in the 4 weeks prior to visit 1
- Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
- Have had a myocardial infarction in the three months prior to enrolment
Show all 19Show fewer
- Have had a cerebral vascular accident in the three months prior to enrolment
- Have had major ocular surgery in the three months prior to enrolment
- Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- Have a known cerebral, aortic or abdominal aneurysm
- Be breast feeding or pregnant, or plan to become pregnant while in the study
- Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
- Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
- Have a known allergy to mannitol
- Be using beta blockers
- Have uncontrolled hypertension - 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 patient's participation in the study
- Be 'Mannitol Tolerance Test positive'
- -
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
United States28 sites
Children's Chest Associates of Austin
Austin, Texas, 78723
John Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 62114
Women and Childrens Hospital of Buffalo
Buffalo, New York, 14222
Medical University of SC
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Missouri
Columbia, Missouri, 65212
Central Connecticut Cystic Fibrosis Center
Hartford, Connecticut, 66106
Baylor College of Medicine
Houston, Texas, 77030
St Lukes CF Center of Idaho
Idaho City, Idaho, 83712
Nemours Childrens Clinic
Jacksonville, Florida, 32207
University of Wisconsin
Madison, Wisconsin, 53972
Le Bonheur Children's Medical Center
Memphis, Tennessee, 38105
Batchelor Children's Research Institute - University of Miami
Miami, Florida, 33136
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Nebraska Medical Center - Nebraska Regional CF Center
Omaha, Nebraska, 68198-5300
Nemours Children's Clinic Orlando
Orlando, Florida, 32801
St Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Maine Pediatric Specialty Group
Portland, Maine, 4102
Pediatric Research, VCU Medical Centre
Richmond, Virginia, 23298
Virginia Commonwealth University
Richmond, Virginia, 23298
Alamo Clinical Research Associates
San Antonio, Texas, 78212
Christus Santa Rosa Children's Hospital Cystic Fibrosis Center
San Antonio, Texas, 78229-3900
University of Washington medical centre
Seattle, Washington, 58103
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130-3932
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57117
The Toledo Hospital and Toledo Childrens Hospital
Toledo, Ohio, 43606
University of Arizona
Tucson, Arizona, 85724
Argentina8 sites
Hospital Interzonal Dr Jose Penna Bahia Blanca
Bahía Blanca, Buenos Aires, 8000
Atención Integral en Reumatologia (AIR)
Buenos Aires, C1426AAL
Hospital de Ninos Dr Ricardo Gutierrez, Pediatria
CABA, Buenos Aires, C1425EFD
Hospital Gral. de Ninos Pedro de Elizalde
Ciudad Autonoma, Buenos Aires, C1270AAN
Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba
Córdoba, 5000
Hospital de Ninos del la Santisima Trinidad
Córdoba, 5000
Hospital de Ninos Superiora Sor Maria Ludovica de La Plata
La Plata, Buenos Aires, 1900
Hospital Pediatrico Dr Humberto J Notti
Villa Nueva, Mendoza Province, 5519
France6 sites
Hopital Femme-Mere-Enfents
Bron, Lyon, 69677
Hopital Andre Mignot
Le Chesnay, Cedix, 78157
Hopital Jeanne de Flandre
Lille, Lille, 59037
Hopital Mere-Enfant
Nantes, Cedex, 44093
Hopital Robert Debre
Paris, 75019
Hopital de Hautepierre
Strasbourg, Strasbourg, 67098
Belgium4 sites
Hopital Universitaire Reine Fabiola
Brussels, Brussels Capital, 1090
UZ Brussel Laarbeeklan 101
Brussels, 1090
Pediatrics Respiratory Medicine
Edegem, Antwerpen, 2650
UZ Gasthuisberg
Leuven, 3000
Canada3 sites
Foothills medical center
Calgary, Alberta, T2N4N1
QEII Health Sciences Center
Halifax, Nova Scotia, B3H3A7
The Children's Asthma Clinic
London, Ontario, N6A1V2
Germany3 sites
University of Munich Medizinischen Klinik Innenstadt
München, 80336
Universitats Kinderklinik Tubungen Wurzburg
Tübingen, 72076
Universitats Kinderklinik Wurzburg
Würzburg, 97080
About this study
Official title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
- Conditions
- Cystic Fibrosis
- Being tested
- inhaled mannitol, Placebo comparator
- Keywords
- cystic fibrosis, mannitol, mucoactive
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled mannitolDrug
400 mg BD for 26 + 26 weeks
Placebo comparatorDrug
BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | active treatment Receives: Drug: inhaled mannitol |
| B | Placebo comparator | Not described Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Absolute FEV1 From Baseline Over 26 Weeks
Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) 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.
Measured: 26 weeks
Secondary outcomes (8)
Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
In the subset of dornase users, the mean absolute change from baseline FEV1 (mL) averaged 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.
Change from baseline over 26 weeks (measured at 6,14, 26 weeks) in subset of dornase users
Measured: 26 weeks
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
Exacerbations treated with IV antibiotics and with at least 4 signs and symptoms according to Fuchs criteria (1994). Summary table presents the number with 0, 1,2 and 3 PDPEs during the 26 week treatment period.
Measured: 26 weeks
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
The number of hospitalisations is summarised and then the rate per person is analysed.
Measured: 26 weeks
Antibiotic Use Associated With PDPEs
Number of courses per person in the 26 week period is summarised and then the rate per person analysed.
Measured: 26 weeks
Absolute Change in FEV1 Percent Predicted at 26 Weeks
Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26
Measured: 26 weeks
Change in FVC (mL) Across 26 Weeks
Change from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks)
Measured: 26 weeks
Change From Baseline FEF25-75 (mL/s) Over 26 Weeks
Change from baseline in forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) (mL/s) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline over 26 weeks (measured at week 6, 14 and 26) was 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.
Measured: 26 weeks
Sputum Weight at Baseline in Response to First Dose of Treatment
Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment.
Measured: up to 30 mins after first dose of trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc., Europe: KasaConsult bvba, Hoegaarden, Belgium, Resolution Latin America
- Responsible party
- Sponsor
- Investigators
- Moira L Aitken, MD, Principal investigator, University of Washington Medical Centre, Seattle WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630812
- Sponsor's protocol ID
- DPM-CF-302
- Status last verified
- Oct 2020
- First submitted
- 27 Feb 2008
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. doi: 10.1089/jam.2006.19.100.
PubMed 16551221Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56. doi: 10.1111/j.1440-1843.2005.00659.x.
PubMed 15691238Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. doi: 10.1089/089426802760292681.
PubMed 12396422Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.
PubMed 11921459Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21. doi: 10.1378/chest.119.2.414.
PubMed 11171717Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85. doi: 10.1034/j.1399-3003.1999.14c30.x.
PubMed 10543292Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8. doi: 10.1164/ajrccm.159.6.9809074.
PubMed 10351929Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54. doi: 10.1183/09031936.97.10112449.
PubMed 9426077Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouef PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.
PubMed 18339790Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5(5):CD008649. doi: 10.1002/14651858.CD008649.pub4.
PubMed 32358807Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.
PubMed 22198974
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT00630812
- Acronym / sponsor ID
- DPM-CF-302
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, mannitol, mucoactive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc., Europe: KasaConsult bvba, Hoegaarden, Belgium, Resolution Latin America
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: inhaled mannitolactive treatment |
| B | Placebo comparator | Drug: Placebo comparator |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have given written informed consent to participate in this study 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 > 6 years old
- Have FEV1 >40 % and < 90% predicted
- Be able to perform all the techniques necessary to measure lung function
Key exclusion criteria (19 listed)
- Investigators, site personnel directly affiliated with this study, 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 nebulized hypertonic saline in the 4 weeks prior to visit 1
- Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled mannitol400 mg BD for 26 + 26 weeks | Drug | A |
| Placebo comparatorBD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase | Drug | B |
Primary outcome
Change in Absolute FEV1 From Baseline Over 26 Weeks
Time frame: 26 weeks
Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) 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.
8 secondary outcomes
Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
Time frame: 26 weeks
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
Time frame: 26 weeks
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
Time frame: 26 weeks
Antibiotic Use Associated With PDPEs
Time frame: 26 weeks
Absolute Change in FEV1 Percent Predicted at 26 Weeks
Time frame: 26 weeks
Change in FVC (mL) Across 26 Weeks
Time frame: 26 weeks
Change From Baseline FEF25-75 (mL/s) Over 26 Weeks
Time frame: 26 weeks
Sputum Weight at Baseline in Response to First Dose of Treatment
Time frame: up to 30 mins after first dose of trial treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16551221Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. doi: 10.1089/jam.2006.19.100.
- Background: PubMed 15691238Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56. doi: 10.1111/j.1440-1843.2005.00659.x.
- Background: PubMed 12396422Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. doi: 10.1089/089426802760292681.
- Background: PubMed 11921459Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.
- Background: PubMed 11171717Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21. doi: 10.1378/chest.119.2.414.
- Background: PubMed 10543292Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85. doi: 10.1034/j.1399-3003.1999.14c30.x.
- Background: PubMed 10351929Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8. doi: 10.1164/ajrccm.159.6.9809074.
- Background: PubMed 9426077Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54. doi: 10.1183/09031936.97.10112449.
- Background: PubMed 18339790Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouef PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.
- Derived from this study: PubMed 32358807Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5(5):CD008649. doi: 10.1002/14651858.CD008649.pub4.
- Derived from this study: PubMed 22198974Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moira L Aitken, MD principal investigator
University of Washington Medical Centre, Seattle WA
53 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing inhaled mannitol in people with Cystic Fibrosis, run by Syntara at 53 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Argentina, France, Belgium, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Absolute FEV1 From Baseline Over 26 Weeks (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630812, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.