AsthmaPhase 3BUFODILNCT02308098
To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product
A Phase 3 study testing Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh, Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh and Symbicort Turbuhaler 320/9 ug/inhalation 4 inh in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Bulgaria.
Trial summary
The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh, Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh and Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBulgaria
- Study dates
- Dec 2014to Jun 2015
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- Written informed consent
- Asthma diagnosis for at least 6 months
- Prebronchodilator FEV1 45-90% of the predicted value
- Demonstration of reversible airway obstruction
- Stable asthma on the same regular treatment for at least 4 weeks before the study
- Non-smoker for at least 6 months before the study
Main exclusion criteria
- Respiratory infection within 4 weeks before the study
- Smoking history of more than 10 pack-years
- Other severe chronic respiratory disease than asthma
- Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study
- Corrected QT interval > 450 ms in males or > 470 ms in females
- Abnormal serum potassium value or other clinically significant laboratory finding
- Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg
- Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study
- Use of drugs that prolong QT-interval
- Women who are pregnant, breast-feeding or without reliable contraception
- Participation in another clinical drug study
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Rousse
About this study
Official title: Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects
The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
- Conditions
- Asthma
- Being tested
- Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh, Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh, Symbicort Turbuhaler 320/9 ug/inhalation 4 inh, Symbicort Turbuhaler 320/9 ug/inhalation 1inh, Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inhDrug
Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inhDrug
Symbicort Turbuhaler 320/9 ug/inhalation 4 inhDrug
Symbicort Turbuhaler 320/9 ug/inhalation 1inhDrug
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inhDrug
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inhDrug
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inhDrug
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inhDrug
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh | Experimental | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Receives: Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh; Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh |
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh | Experimental | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Receives: Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh; Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Experimental | Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Receives: Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Experimental | Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Receives: Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average FEV1
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
Measured: 12 h
Secondary outcomes (2)
Maximum FEV1
Maximum FEV1 over the 12-hour serial assessments
Measured: 12 h
FEV1 at 12 h
FEV1 at 12 hours post-dose
Measured: 12 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hristo Metev, MD, Principal investigator, Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308098
- Sponsor's protocol ID
- 3103013
- Acronym
- BUFODIL
- Status last verified
- Jan 2015
- First submitted
- 2 Dec 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25.
PubMed 27817813
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT02308098
- Acronym / sponsor ID
- BUFODIL / 3103013
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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 purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh | Experimental | Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh, Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inhBudesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh |
| Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh | Experimental | Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh, Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inhBudesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Experimental | Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh, Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inhSymbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Experimental | Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh, Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inhSymbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh | Drug | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh |
| Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh | Drug | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Drug | Symbicort Turbuhaler 320/9 ug/inhalation 4 inh |
| Symbicort Turbuhaler 320/9 ug/inhalation 1inh | Drug | Symbicort Turbuhaler 320/9 ug/inhalation 1 inh |
| Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Drug | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh |
| Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh | Drug | Symbicort Turbuhaler 320/9 ug/inhalation 4 inh |
| Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh | Drug | Symbicort Turbuhaler 320/9 ug/inhalation 1 inh |
| Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Drug | Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh |
Primary outcome
Average FEV1
Time frame: 12 h
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
2 secondary outcomes
Maximum FEV1
Time frame: 12 h
FEV1 at 12 h
Time frame: 12 h
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 30 Jun 2015.
- Derived from this study: PubMed 27817813Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25.
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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.
Hristo Metev, MD principal investigator
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh, Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh and Symbicort Turbuhaler 320/9 ug/inhalation 4 inh in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Average FEV1 (time frame: 12 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308098, which also lists 1 linked publication.
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 30 Jun 2015.