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Pharmaceutical guidance for optimizing the use of asthma medications

Pharmaceutical intervention to optimize the use of inhalation devices in asthma patients: a randomized, open clinical tirial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9kkjvnj
Enrollment
Unknown
Registered
2023-10-27
Start date
2023-12-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Asthma

Interventions

This is a randomized controlled clinical study with two arms, double-blind. The pilot study will be conducted for 15 days, during which approximately 10 patients are intended to be included. This stag
Umeclidinium bromide + vilanterol trifenatate (62.5mcg + 25mcg), Ellipta© System with inhalable powder (DI2)
Tiotropium monohydrate bromide + olodaterol hydrochloride (2.5mcg + 2.5mcg), Respimat© System with pressurized solution (DI3). Pharmaceutical Guidance: Pharmaceutical guidance involves an educational
I02.233.332

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Secretaria de Estado da Saúde Pública do Rio Grande do Norte - SESAP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Both sexes. Aged 18 years or older. Confirmed diagnosis of Asthma through spirometry. Patients currently using or starting the use of a dry powder inhaler (Aerolizer, Turbuhaler) and/or inhalation solution (Respimat system) on D0. Informed and voluntary consent to participate in the clinical trial

Exclusion criteria

Exclusion criteria: Conditions that may influence the learning of the inhalation technique (psychiatric, neurological, or rheumatological disorders). Presence of respiratory diseases other than asthma. Ongoing viral or bacterial respiratory infection. Dependency on third parties for DI handling. Hearing impairment. Severe visual impairment. Treatment with a different DI other than Aerolizer, Turbuhaler, and Respimat. Active smoking. Undergoing respiratory physiotherapy

Design outcomes

Primary

MeasureTime frame
To confirm the effectiveness of pharmaceutical guidance and its potential community-level impact

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactRodrigo Diniz

Universidade Federal do Rio Grande do Norte

rodrigo.diniz@ufrn.br+55(84)33429822

Outcome results

None listed

Source: REBEC (via WHO ICTRP)