Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

NCT05084222 | Completed Phase 4

• 1 other identifier: 0010032
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler. This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in one second (FEV1)

  Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.

  10 minutes

Secondary Outcomes (3)

• Number of subjects who recover from bronchoconstriction after first dose

  10 minutes

• Forced expiratory volume in one second (FEV1)

  10 minutes

• Number of subjects who recover from bronchoconstriction after second dose

  20 minutes

Other Outcomes (2)

• Number of patients needing medical attention

  After study treatment administration until study completion (an average of 2.5 hours)

• Inhalation profile via Easyhaler

  Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry

Study Arms (3)

Buventol® Easyhaler® 200 µg/inhalation dmDPI

EXPERIMENTAL

400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.

Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

EXPERIMENTAL

320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations.

Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

Ventoline® Evohaler® 100 µg/inhalation pMDI

ACTIVE COMPARATOR

400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.

Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI

Interventions

Buventol® Easyhaler® 200 µg/inhalation dmDPI DRUG

Two doses will be administered

Also known as: Salbutamol 200 µg/dose dmDPI

Buventol® Easyhaler® 200 µg/inhalation dmDPI

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI DRUG

Two doses will be administered

Also known as: Budesonide/formoterol 160/4.5 µg/inhalation dmDPI

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

Ventoline® Evohaler® 100 µg/inhalation pMDI DRUG

Four doses will be administered via Volumatic spacer

Also known as: Salbutamol 100 µg/dose MDI

Ventoline® Evohaler® 100 µg/inhalation pMDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent (IC) obtained.
• Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.
• The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.

You may not qualify if:

• Subjects not eligible for methacholine challenge test for example for any of the following reasons:
• Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit
• FEV1 \< 60% of predicted or \< 1.0 l
• Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure
• Uncontrolled hypertension
• Acute chest pain or unstable angina pectoris
• Significant cardiac arrhythmias
• Pneumothorax or recent bronchoscopy
• Myocardial infarction or stroke in last 3 months
• Known aortic aneurysm
• Recent eye surgery or intracranial pressure elevation risk
• Cholinesterase inhibitor medication
• Pregnant or lactating females
• Subjects who have used the following treatments before the study visit:
• Short-acting β-agonists within 12 h

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (2)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Budesonide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lauri Lehtimäki

  Tampere University Hospital, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 19, 2021
• Study Start: November 11, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)