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Dry powder inhalation in patients with Parkinson’s disease.

Investigation of the applicability of dry powder inhalation in patients with Parkinson’s disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24879
Enrollment
15
Registered
2013-10-08
Start date
2013-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Ability of a Parkinson’s patient to use the inhaler correctly during off periods.

Interventions

testing if they can generate a sufficiently large airflow and volume through a test inhaler.

Sponsors

Department of Pharmaceutical Technology and Biopharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Peak and mean inspiratory flow rate (PIFR and MIFR). Acceleration towards peak inspiratory flow rate (flow increase rate: FIR). Inhaled volume. Total inhalation time.

Contacts

Public ContactM. Luinstra

RVE klinische farmacie Van Swietenplein 1 Postbus 30033

m.luinstra@mzh.nl050-5245771

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)