Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway

Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway; A Retrospective, Observational Study to Evaluate the Impact on Disease Control in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04663386

Acronym

BufoSwitch

Enrollment

Registered

2020-12-11

Start date

2020-12-10

Completion date

2021-09-14

Last updated

2021-09-23

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

Conditions

Asthma, COPD

Brief summary

This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.

Detailed description

In July 2018 Norwegian authorities decided to allow switch at pharmacy for dry powder inhalers (DPIs) containing budesonide-formoterol. Pharmacists are instructed to switch patients to the inhaler with the lowest price. The pharmacist will train the patient on how to use the new inhaler. All patients whose eligible inhaler switch occurred between 1st July 2018 and 1st March 2019 will be eligible for the study.

Interventions

DRUGBudesonide-Formoterol

Dry powder inhaler

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Written informed consent has been obtained. 2. Male or female patients with a diagnosis of asthma and/or COPD whose budesonide-formoterol DPI was switched to another budesonide-formoterol DPI at pharmacy between 1st July 2018 and 1st March 2019 (referred to as the eligible switch). 3. Age ≥12 years at time of switch. 4. Treated with budesonide-formoterol for at least 12 months before the eligible switch (pre-switch period) and 12 months after the eligible switch (post-switch period). Re-switch(es) of inhaler are allowed during the post-switch period.

Exclusion criteria

1\. Patient has declined participation in the study or failed to respond to the invitation to participate.

Design outcomes

Primary

Measure	Time frame	Description
Disease control	24 months	The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch.

Secondary

Measure	Time frame	Description
Budesonide-formoterol dose	24 months	The change in the treatment dose of budesonide-formoterol at the time of the eligible switch and at the end of the post-switch period (e.g. 12 months post-switch).
Training at pharmacy	24 months	The correlation between inhaler training given at pharmacy and exacerbations.
Healthcare utilisation	24 months	The number of asthma and/or COPD related hospitalisations, emergency room visits and visits to physicians 12 months pre-switch and 12 months post-switch.
Inhaler switch	24 months	The number of re-switches after the first 'eligible' switch and the reasons for that switch.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026