Asthma CopdPhase 3ESPIRENCT04233190
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
A Phase 3 study testing Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg in people with Asthma Copd, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma Copd
- What is being tested?
- Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Apr 2023to 30 Oct 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years
- Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.
Who cannot join
- Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
- Presence of acute or chronic symptomatic airway infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD).
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Read the detailed description
In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes the potential bias arising from the open label of the study.
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
- Conditions
- Asthma Copd
- Being tested
- Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcgDrug
Also called fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg
one inhalation, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg) | Experimental | Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg Receives: Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg |
| Alenia® (12/400mcg e 6/200mcg) | Active comparator | Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg Receives: Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Average change from baseline in pre-dose Forced Expiratory Volume in one second
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start19 Apr 2023
- Primary completion28 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma CopdStudies 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
- Parallel groups
- Model description
- In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233190
- Sponsor's protocol ID
- EF162
- Acronym
- ESPIRE
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD
- ClinicalTrials.gov ID
- NCT04233190
- Acronym / sponsor ID
- ESPIRE / EF162
- Conditions
- Asthma Copd
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 18 Jan 2020 (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.
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD).
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Detailed description
In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes the potential bias arising from the open label of the study.
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
| Arm | Type | Receives |
|---|---|---|
| Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg) | Experimental | Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcgFormoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg |
| Alenia® (12/400mcg e 6/200mcg) | Active comparator | Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcgAlenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 12 years
- Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.
Key exclusion criteria (2 listed)
- Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
- Presence of acute or chronic symptomatic airway infection.
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 |
|---|---|---|
| Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcgAlso: fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcgone inhalation, twice daily | Drug | Alenia® (12/400mcg e 6/200mcg), Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg) |
Primary outcome
FEV1
Time frame: 24 weeks
Average change from baseline in pre-dose Forced Expiratory Volume in one second
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 26 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg in people with Asthma Copd, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 2 inclusion and 2 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 26 Oct 2026. 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 Brazil. 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?
FEV1 (time frame: 24 weeks). 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 26 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.