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The use of AKITAŽ JET in cystic fibrosis: Treatment protocol and impact on lung function decline, lung clearance index and imaging.


- candidate number13303
- NTR NumberNTR3627
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2012
- Secondary IDs2012/185 MEC UZ Brussel
- Public TitleThe use of AKITAŽ JET in cystic fibrosis: Treatment protocol and impact on lung function decline, lung clearance index and imaging.
- Scientific TitleThe use of AKITAŽ JET in cystic fibrosis: Treatment protocol and impact on lung function decline, lung clearance index and imaging.
- ACRONYMAKITA study
- hypothesisThe AKITAŽ JET nebulizer is a new inhalation device with breath controlled inhalation. It regulates inspiration flow as well as inhalation volume, taking into account therapeutic requirements and the patient's individual condition. Doing so, it optimizes inhalation patterns, and ensures a higher drug deposition in the lungs.
In this project, we want to examine the influence of the use of the AKITAŽ JET inhalation device on clinical scores, quality of life, pulmonary function and imaging in patients with cystic fibrosis.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), AKITAŽ JET nebuliser, Inhalation therapy
- Inclusion criteria1. Patients with cystic fibrosis (6-65 years);
2. Treated with inhalation medication;
3. Never used AKITAŽ JET before.
- Exclusion criteria1. Patients younger than 6 years;
2. Acute pulmonary exacerbation at day of inclusion.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 6-sep-2012
- planned closingdate6-feb-2013
- Target number of participants50
- InterventionsPatients will use the AKITAŽ JET inhalation device to inhale their medication for 3 months.
- Primary outcome1. Quality of Life;
2. FEV1;
3. LCI;
4. CT Bhalla score.
- Secondary outcomeN/A
- TimepointsVisit 1: Before starting with AKITA;
Visit 2: After 6 weeks;
Visit 3: After 3 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. J. Willekens
- CONTACT for SCIENTIFIC QUERIESMD. J. Willekens
- Sponsor/Initiator University Hospital Brussels, Cystic Fibrosis Reference Center
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Brussels, Cystic Fibrosis Reference Center
- PublicationsN/A
- Brief summaryThe AKITAŽ JET nebulizer is a new inhalation device with breath controlled inhalation. It regulates inspiration flow as well as inhalation volume, taking into account therapeutic requirements and the patient's individual condition. Doing so, it optimizes inhalation patterns, and ensures a higher drug deposition in the lungs.
In this project, we want to examine the influence of the use of the AKITAŽ JET inhalation device on clinical scores, quality of life, pulmonary function and imaging in patients with cystic fibrosis.
- Main changes (audit trail)
- RECORD11-sep-2012 - 7-okt-2012


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