AsthmaPhase 4EASYRELIEFNCT05084222
Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing
A Phase 4 study testing Buventol® Easyhaler® 200 µg/inhalation dmDPI, Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI and Ventoline® Evohaler® 100 µg/inhalation pMDI in people with Asthma, run by Orion Corporation, Orion Pharma at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Buventol® Easyhaler® 200 µg/inhalation dmDPI, Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI and Ventoline® Evohaler® 100 µg/inhalation pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFinland
- Study dates
- 11 Nov 2021to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Long-acting β-agonists within 36 h
- Ultra-long-acting β-agonists within 48 h
- Long-acting anti-muscarinic agents within 168 h
- Short-acting anticholinergics within 12 h
- Oral theophylline within 24 h
- Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks
- Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).
- Administration of another investigational medicinal product within 30 days before the study visit.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Hospital
Helsinki, 00029
Tampere University Hospital
Tampere, 33520
About this study
Official title: Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects
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
- Being tested
- Buventol® Easyhaler® 200 µg/inhalation dmDPI, Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI, Ventoline® Evohaler® 100 µg/inhalation pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buventol® Easyhaler® 200 µg/inhalation dmDPIDrug
Also called Salbutamol 200 µg/dose dmDPI
Two doses will be administered
Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPIDrug
Also called Budesonide/formoterol 160/4.5 µg/inhalation dmDPI
Two doses will be administered
Ventoline® Evohaler® 100 µg/inhalation pMDIDrug
Also called Salbutamol 100 µg/dose MDI
Four doses will be administered via Volumatic spacer
| Study group | Role | What they receive |
|---|---|---|
| Buventol® Easyhaler® 200 µg/inhalation dmDPI | Experimental | 400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations. Receives: 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. Receives: 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. Receives: Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.
Measured: 10 minutes
Secondary outcomes (3)
Number of subjects who recover from bronchoconstriction after first dose
Proportion of the subjects who recover to FEV1 > -10% compared to post-diluent FEV1 after first dose of reliever.
Measured: 10 minutes
Forced expiratory volume in one second (FEV1)
Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1.
Measured: 10 minutes
Number of subjects who recover from bronchoconstriction after second dose
Proportions of subjects reaching FEV1 > -10% of post-diluent value after second dose of reliever.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start11 Nov 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauri Lehtimäki, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084222
- Sponsor's protocol ID
- 0010032
- Acronym
- EASYRELIEF
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects
- ClinicalTrials.gov ID
- NCT05084222
- Acronym / sponsor ID
- EASYRELIEF / 0010032
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buventol® Easyhaler® 200 µg/inhalation dmDPI | Experimental | Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations. |
| Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI | Experimental | Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations. |
| Ventoline® Evohaler® 100 µg/inhalation pMDI | Active comparator | Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (23 listed)
- Subjects not eligible for methacholine challenge test for example for any of the following reasons:
- Subjects who have used the following treatments before the study visit:
- Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).
- Administration of another investigational medicinal product within 30 days before the study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buventol® Easyhaler® 200 µg/inhalation dmDPIAlso: Salbutamol 200 µg/dose dmDPITwo doses will be administered | Drug | Buventol® Easyhaler® 200 µg/inhalation dmDPI |
| Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPIAlso: Budesonide/formoterol 160/4.5 µg/inhalation dmDPITwo doses will be administered | Drug | Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI |
| Ventoline® Evohaler® 100 µg/inhalation pMDIAlso: Salbutamol 100 µg/dose MDIFour doses will be administered via Volumatic spacer | Drug | Ventoline® Evohaler® 100 µg/inhalation pMDI |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 10 minutes
Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.
3 secondary outcomes
Number of subjects who recover from bronchoconstriction after first dose
Time frame: 10 minutes
Forced expiratory volume in one second (FEV1)
Time frame: 10 minutes
Number of subjects who recover from bronchoconstriction after second dose
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauri Lehtimäki principal investigator
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buventol® Easyhaler® 200 µg/inhalation dmDPI, Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI and Ventoline® Evohaler® 100 µg/inhalation pMDI in people with Asthma, run by Orion Corporation, Orion Pharma at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.