AsthmaPhase 3UNIKNCT01167010

A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

A Phase 3 study testing Formoterol/Budesonide, Foraseq and Alenia in people with Asthma, run by Eurofarma Laboratorios S.A. at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients'… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Formoterol/Budesonide, Foraseq and Alenia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 552 participants
Where: 5 sitesBrazil
Study dates: Apr 2011to Feb 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Sign the ICF;
≥ 12 years old;
Have a diagnosis of mild to moderate persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test <3,0;
Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent);
Initial FEV1 of at least 50% of the normal value expected;
Serum cortisol evaluation within the normal limits

Who cannot join

Use of oral or parenteral corticosteroid within the last 3 months before the study;
Hospitalization needed due to asthma within the last 3 months before the study;
Active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months;
Presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma;
Recent participation (<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma;
Intolerance or allergy to any component of the drugs evaluated in the study;
Pregnant or lactating women;
Chronic use of routine β-blockers orally or intravenously, including ophthalmic solutions.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

Hospital de Clinicas UFPR
Curitiba, Paraná
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, Estado de Bahia
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, São Paulo
Stelmach Pesquisa Clinica
São Paulo, São Paulo
Clinica de Alergia Martti Antila
Sorocaba, São Paulo

Other trials in Brazil

About this study

Official title: A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients

Read the detailed description

Conditions: Asthma
Being tested: Formoterol/Budesonide, Foraseq, Alenia
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Formoterol/BudesonideDrug
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
ForaseqDrug
Also called Formoterol/Budesonide
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
AleniaDrug
Also called Formoterol/Budesonide
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Study groups in NCT01167010
Study group	Role	What they receive
Formoterol/Budesonide	Experimental	formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. Receives: Drug: Formoterol/Budesonide
Foraseq	Active comparator	Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. Receives: Drug: Foraseq
Alenia	Active comparator	Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. Receives: Drug: Alenia

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
The primary efficacy analysis was performed by evaluating non-inferiority of Eurofarma's device compared to Alenia® in relation to FEV1 (in liters) in FV in the PP population
Measured: 12 weeks

Secondary outcomes (1)

FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups
The mean FEV1 (L) in VF were compared between the three groups using the nonparametric Kruskal-Walllis test and the ITT population. A nonparametric test was used since the variable did not show normal distribution in the Foraseq® group.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Feb 2012

First posted21 Jul 2010 (estimated)
Study startApr 2011
Primary completionAug 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Parallel groups
Masking: None (open label)
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01167010
Sponsor's protocol ID: EF111
Acronym: UNIK
Status last verified: Mar 2025
First submitted: 20 Jul 2010
Last updated: 1 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients
ClinicalTrials.gov ID: NCT01167010
Acronym / sponsor ID: UNIK / EF111
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Aug 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 21 Jul 2010 (estimated)
Results: Posted 1 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Formoterol/Budesonide	Experimental	Drug: Formoterol/Budesonideformoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
Foraseq	Active comparator	Drug: ForaseqForaseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Alenia	Active comparator	Drug: AleniaAlenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Sign the ICF;
≥ 12 years old;
Have a diagnosis of mild to moderate persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test <3,0;
Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent);
Initial FEV1 of at least 50% of the normal value expected;

Key exclusion criteria (8 listed)

Use of oral or parenteral corticosteroid within the last 3 months before the study;
Hospitalization needed due to asthma within the last 3 months before the study;
Active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months;
Presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma;
Recent participation (<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma;

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
Formoterol/Budesonideformoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.	Drug	Formoterol/Budesonide
ForaseqAlso: Formoterol/Budesonideforaseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.	Drug	Foraseq
AleniaAlso: Formoterol/BudesonideAlenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.	Drug	Alenia

Primary outcome

Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
Time frame: 12 weeks
The primary efficacy analysis was performed by evaluating non-inferiority of Eurofarma's device compared to Alenia® in relation to FEV1 (in liters) in FV in the PP population

1 secondary outcome

FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups
Time frame: 12 weeks

Results and safety

Results posted to the registry on 1 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Formoterol/Budesonide	184	154
Foraseq	184	145
Alenia	184	151

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Liter

Measure	Formoterol/Budesonide n = 154	Alenia n = 150
Value	2.53 (0.79)	2.51 (0.77)

Population analysed: The study aims to demonstrate the non-inferiority of the FEV1 (in liters) at the final visit (FV) in the per-protocol (PP) population results for the Formoterol/Budesonide product compared to Alenia.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Formoterol/Budesonide	1 of 154 (0.6%)	1 of 154 (0.6%)	Not reported
Foraseq	0 of 145 (0%)	0 of 145 (0%)	Not reported
Alenia	0 of 151 (0%)	0 of 151 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 1
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RecruitingObservational study
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RecruitingObservational study
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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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Formoterol/Budesonide, Foraseq and Alenia in people with Asthma, run by Eurofarma Laboratorios S.A. at 5 sites 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 6 inclusion and 8 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 1 Second (FEV1) at the Final Visit (FV) (time frame: 12 weeks). 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 NCT01167010.

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 1 May 2025.