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Dry powder inhalation in patients with Parkinsonís disease.


- candidate number15525
- NTR NumberNTR4202
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2013
- Secondary IDs 45210.099.13 RTPO 906
- Public TitleDry powder inhalation in patients with Parkinsonís disease.
- Scientific TitleInvestigation of the applicability of dry powder inhalation in patients with Parkinsonís disease.
- ACRONYM
- hypothesisThe development of a dry powder inhaler (DPI) that suits the needs of Parkinsonís patients, based on their inspiratory capacities, is essential. In this study, we will investigate the applicability of dry powder inhalation in Parkinsonís patients, in order to enable us to develop a DPI specifically for this patient group, by testing if they can generate a sufficiently large airflow and volume through the test inhaler theoretically necessary to disperse a medicinal powder and transport the aerosol into the lower airways during an off period.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Dry powder inhalation
- Inclusion criteriaPredictable off periods.
Recognizable off periods for themselves and others.
At least 2 years of levodopa use.
Signed informed consent.
Diagnosed with Parkinsonís disease according to the UK Parkinsonís disease society Brain Bank Clinical Diagnostic Criteria
- Exclusion criteriaCognitive dysfunction, which precludes good understanding of instructions and/or informed consent.
Current treatment with apomorphine or duodopa by pump.
Any chronic pulmonary disease; (asthma, copd, pulmonary fibrosis, pulmonary emphysema, pulmonary gas diffusion disorders, etc).
Lung cancer or a history of lung cancer (if not cancer free for at least 5 years).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2013
- planned closingdate1-dec-2014
- Target number of participants15
- Interventionstesting if they can generate a sufficiently large airflow and volume through a test inhaler.
- Primary outcomeThe parameter that describes whether or not a Parkinsonís patient is capable of using the inhaler correctly is the pressure drop (s)he creates over the inhaler upon inhalation.
- Secondary outcomePeak and mean inspiratory flow rate (PIFR and MIFR). Acceleration towards peak inspiratory flow rate (flow increase rate: FIR). Inhaled volume. Total inhalation time.
- TimepointsPressure drop: Time point: during testing. The study will be conducted with an instrumented test inhaler with exchangeable air flow resistances. The device is provided with a pressure drop meter that records the pressure drop that is generated when the patient inhales through it. The pressure drop meter is linked to a computer equipped with software that calculates from the pressure drop the inspiratory flow rate as function of the inhalation time. Various relevant parameters can be derived from this curve, such as inhaled volume, total inhalation time and peak inspiratory flow rate.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M. Luinstra
- CONTACT for SCIENTIFIC QUERIES M. Luinstra
- Sponsor/Initiator University of Groningen
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryThe development of a dry powder inhaler (DPI) that suits the needs of Parkinsonís patients, based on their inspiratory capacities, is essential. In this study, we will investigate the applicability of dry powder inhalation in Parkinsonís patients, in order to enable us to develop a DPI specifically for this patient group, by testing if they can generate a sufficiently large airflow and volume through the test inhaler theoretically necessary to disperse a medicinal powder and transport the aerosol into the lower airways during an off period.
Recruiting will take place in The Netherlands
- Main changes (audit trail)
- RECORD8-okt-2013 - 7-okt-2014


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