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

NCT ID: NCT04663386

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-09-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Budesonide-Formoterol

Dry powder inhaler

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jorn Ossum

Role: PRINCIPAL_INVESTIGATOR

Flattum Legesenter

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Flattum Legesenter

Hønefoss, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3103018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase I Pharmacokinetic Study (BF-BLOCK)
NCT01423305 COMPLETED PHASE1