The development of a dry powder inhaler (DPI) that suits the needs of Parkinson’s patients, based on their inspiratory capacities, is essential. In this study, we will investigate the applicability of dry powder inhalation in Parkinson’s patients,…
ID
Bron
Aandoening
Ability of a Parkinson’s patient to use the inhaler correctly during off periods.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The parameter that describes whether or not a Parkinson’s patient is capable of using the inhaler correctly is the pressure drop (s)he creates over the inhaler upon inhalation.
Achtergrond van het onderzoek
The development of a dry powder inhaler (DPI) that suits the needs of Parkinson’s patients, based on their inspiratory capacities, is essential. In this study, we will investigate the applicability of dry powder inhalation in Parkinson’s 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
Doel van het onderzoek
The development of a dry powder inhaler (DPI) that suits the needs of Parkinson’s patients, based on their inspiratory capacities, is essential. In this study, we will investigate the applicability of dry powder inhalation in Parkinson’s 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.
Onderzoeksopzet
Pressure 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.
Onderzoeksproduct en/of interventie
testing if they can generate a sufficiently large airflow and volume through a test inhaler.
Algemeen / deelnemers
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Wetenschappers
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Predictable off periods.
Recognizable off periods for themselves and others.
At least 2 years of levodopa use.
Signed informed consent.
Diagnosed with Parkinson’s disease according to the UK Parkinson’s disease society Brain Bank Clinical Diagnostic Criteria
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Cognitive 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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4036 |
| NTR-old | NTR4202 |
| Ander register | RTPO 906 : 45210.099.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |