Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02134353 |
Date of registration:
|
16/04/2014 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
|
Scientific title:
|
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects |
Date of first enrolment:
|
September 2014 |
Target sample size:
|
423 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02134353 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
Phase:
|
Phase 3
|
|
Countries of recruitment
|
Argentina
|
Australia
|
Belgium
|
Canada
|
Czech Republic
|
Czechia
|
France
|
Hungary
|
Israel
|
Italy
|
Mexico
|
New Zealand
|
Poland
|
Romania
|
Russian Federation
|
Slovakia
|
South Africa
|
Spain
|
Ukraine
|
United States
| | | | |
Contacts
|
Name:
|
Brett Charlton, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Medical Director |
|
Name:
|
Moira Aitken, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Cystic Fibrosis
|
Intervention(s)
|
Drug: Inhaled mannitol
|
Drug: Placebo Comparator: Arm B - Control
|
Primary Outcome(s)
|
Mean Change in FEV1 (mL) From Baseline (Visit 1) Over the 26-week Treatment Period (to Visit 4).
[Time Frame: 26 weeks]
|
Secondary Outcome(s)
|
Mean Change From Baseline FVC (mL) Over the 26-week Treatment Period
[Time Frame: 26 weeks]
|
Secondary ID(s)
|
DPM-CF-303
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|