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TerminatedNCT04663386BufoSwitchUpdated Sep 23, 2021

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

An observational study in Asthma and COPD, sponsored by Orion Corporation, Orion Pharma. Terminated at 1 site in Norway. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by Orion Corporation, Orion Pharma · Observational

Why this study was terminated
Target recruitment not reached
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
29
Ages
12 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Asthma
  • COPD

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03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 29 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with asthma and/or COPD treated with budesonide-formoterol DPI

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

Exclusion Criteria:

  1. Patient has declined participation in the study or failed to respond to the invitation to participate.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
29 participants (actual)
Patient registry
No

Interventions

  • DrugBudesonide-Formoterol

    Dry powder inhaler

06

What researchers measure

Primary outcomes

  1. Disease control

    The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch.

    Time frame: 24 months

Secondary outcomes

  1. Budesonide-formoterol dose

    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).

    Time frame: 24 months

  2. Training at pharmacy

    The correlation between inhaler training given at pharmacy and exacerbations.

    Time frame: 24 months

  3. Healthcare utilisation

    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.

    Time frame: 24 months

  4. Inhaler switch

    The number of re-switches after the first 'eligible' switch and the reasons for that switch.

    Time frame: 24 months

07

Study locations

1 site
  • Flattum Legesenter
    Hønefoss, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04663386
Lead sponsor
Orion Corporation, Orion Pharma
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Dec 10, 2020
Primary completion
Sep 14, 2021
Completion
Sep 14, 2021
Last update
Sep 23, 2021

Study contacts

Jorn Ossum
principal investigator · Flattum Legesenter

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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