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Daily observation of inhalation of Tobramycine Inhalation Powder (TIP)

Assessment of real life and trained inhalation profiles of Tobramycin Inhalation Powder (TIP) and Tobramycin Inhalation Solution (TIS) TIPTIS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24275
Enrollment
32
Registered
2015-05-05
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Taaislijmziekte Inhalationprofile Inhalatieprofiel Deposition Depositie

Interventions

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 inhal

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Proven CF Maintenance treatment with TIP Age of 6 and older Informed consent by parents or patients

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The main study parameter is the percentage of patients who inhale with a slow/ intermediate/ fast inhalation maneuver while inhaling TIP.

Secondary

MeasureTime frame
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

Contacts

Public ContactH.A.W.M. Tiddens

Erasmus Medical Center, Sophia Children’s Hospital Rotterdam, Department of Pediatric Pulmonology, Dr. Molewaterplein 60

h.tiddens@erasmusmc.nl+31 (0)10 4636690 / +31 (0)10 4636363 (general)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)