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

NCT04663386 | Terminated

• 1 other identifier: 3103018
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; COPD

Outcome Measures

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.

  24 months

Secondary Outcomes (4)

• Budesonide-formoterol dose

  24 months

• Training at pharmacy

  24 months

• Healthcare utilisation

  24 months

• Inhaler switch

  24 months

Interventions

Budesonide-Formoterol DRUG

Dry powder inhaler

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Written informed consent has been obtained.
• 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).
• Age ≥12 years at time of switch.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Flattum Legesenter

Hønefoss, Norway

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jorn Ossum

  Flattum Legesenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: December 10, 2020
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)