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Daily observation of inhalation of Tobramycine Inhalation Powder (TIP)


- candidate number22170
- NTR NumberNTR5212
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mei-2015
- Secondary IDsNL53582.078.15 
- Public TitleDaily observation of inhalation of Tobramycine Inhalation Powder (TIP)
- Scientific TitleAssessment of real life and trained inhalation profiles of Tobramycin Inhalation Powder (TIP) and Tobramycin Inhalation Solution (TIS)
TIPTIS study
- ACRONYMTIPTIS study
- hypothesisPatients in the home situation will mostly inhale forcefully through the TIP inhaler.

A forceful inhalation is associated with cough

A slow and deep inhalation using TIP results in a reduction of cough and more effective completion of a full inhalation maneuver

Patients inhale with a wide variation of tidal volumes while inhaling from a nebulizer
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Inhalation technique
- Inclusion criteriaProven CF
Maintenance treatment with TIP
Age of 6 and older
Informed consent by parents or patients
- Exclusion criteriaRespiratory tract exacerbation at time of TIP month defined as treatment with intravenous antibiotics

Any other acute condition such as otitis media which according to the treating physician will increase the risk of cough during the inhalation maneuvers.

Inability to follow instructions
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jun-2015
- planned closingdate1-jul-2017
- Target number of participants32
- InterventionsDuring the second home visit patients will be instructed to inhale as fast as possible, either the first or the second pair of four inhalations of tobramycin capsules. They will also be asked to inhale from a nebuliser with 0,9% NaCl solution for 10 minutes
- Primary outcomeThe main study parameter is the percentage of patients who inhale with a slow/ intermediate/ fast inhalation maneuver while inhaling TIP.
- Secondary outcomeSecondary study parameters are: Difference in percentage of patients who react with cough immediately during or following TIP inhalation for the slow/intermediate/fast inhalation maneuver, prevalence of errors made in TIP inhalation in the home situation according to scoring items list, percentage of patients able to execute a slow and deep inhalation using TIP, and tidal volume pattern while patients are inhaling from a conventional nebulizer
- Timepoints?
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. H.A.W.M. Tiddens
- CONTACT for SCIENTIFIC QUERIESDr. H.A.W.M. Tiddens
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dr. Tidden
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-mei-2015 - 12-okt-2016


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