No registrations found.
ID
Source
Brief title
Health condition
Cystic Fibrosis
Taaislijmziekte
Inhalationprofile
Inhalatieprofiel
Deposition
Depositie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percentage of patients who inhale with a slow/ intermediate/ fast inhalation maneuver while inhaling TIP.
Secondary outcome
Secondary 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
Study objective
Patients 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
Study design
?
Intervention
During 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
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
Inclusion criteria
Proven CF
Maintenance treatment with TIP
Age of 6 and older
Informed consent by parents or patients
Exclusion criteria
Respiratory 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5080 |
| NTR-old | NTR5212 |
| CCMO | NL53582.078.15 |
| OMON | NL-OMON43918 |