ASTHMAPhase 3CAINASNCT01001364

A Comparative Study Between Foraseq and Formoterol/Budesonide Inhalation Capsules in Patients with Asthma

A Phase 3 study testing Formoterol/Budesonide and Foraseq in people with ASTHMA, run by Eurofarma Laboratorios S.A. at 1 site 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

Who is it for?: Ages 12 years and older
Conditions the study is for: ASTHMA
What is being tested?: Formoterol/Budesonide and Foraseq
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteBrazil
Study dates: Feb 2010to Apr 2011
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

Sign ICF (see Attachment A);
Age ≥12 years old
Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;
Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
Initial FEV1 of at least 50% of the normal value estimated.
Serum cortisol evaluation within the normal values

Who cannot join

Use of oral or parenteral corticosteroids within the last 3 months;
Need of hospitalization due to asthma within the last 3 months;
Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
Recent participation (<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;
Intolerance or allergy to any of the compounds of the drugs evaluated on the study;
Pregnancy or lactation;
Chronic use of routine oral or intravenous β-blocker drugs, even ophthalmic solutions.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Centro de Pesquisa Clínica Stelmach
São Paulo, São Paulo, 05437 010

Other trials in Brazil

About this study

Official title: A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 Μg and Formoterol/ Budesonide Inhalation Capsules 12/200 Μg Eurofarma in Patients with Asthma

Read the detailed description

This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.

This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma.

The secondary endpoints considered for this study are:

Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ;
Peak of expiratory flow (PEF) throughout the study;
Symptoms score at the end of the study;
FEV1 throughout the study;
Treatment safety, including serum cortisol dosage;
Frequency of observed adverse events.

Some eligibility criteria:

Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;

Conditions: ASTHMA
Being tested: Formoterol/Budesonide, Foraseq
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 will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
ForaseqDrug
formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.

Study groups in NCT01001364
Study group	Role	What they receive
Formoterol/Budesonide	Experimental	Not described Receives: Drug: Formoterol/Budesonide
Foraseq	Active comparator	Not described Receives: Drug: Foraseq

What is being measured

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

The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
Measured: 4 months

Secondary outcomes (1)

Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.
Measured: 4 months

Timeline

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

Feb 2010Apr 2011

First posted26 Oct 2009 (estimated)
Study startFeb 2010
Primary completionApr 2011
Study completionApr 2011

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01001364
Sponsor's protocol ID: EF-091
Acronym: CAINAS
Status last verified: Mar 2025
First submitted: 23 Oct 2009
Last updated: 19 Mar 2025
Results posted: No
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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Enrolling by invitationObservational study
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RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
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Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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All ASTHMA trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 Μg and Formoterol/ Budesonide Inhalation Capsules 12/200 Μg Eurofarma in Patients with Asthma
ClinicalTrials.gov ID: NCT01001364
Acronym / sponsor ID: CAINAS / EF-091
Conditions: ASTHMA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 26 Oct 2009 (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.

Detailed description

The secondary endpoints considered for this study are:

Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ;
Peak of expiratory flow (PEF) throughout the study;
Symptoms score at the end of the study;
FEV1 throughout the study;
Treatment safety, including serum cortisol dosage;
Frequency of observed adverse events.

Some eligibility criteria:

Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Formoterol/Budesonide	Experimental	Drug: Formoterol/Budesonide
Foraseq	Active comparator	Drug: Foraseq

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 ICF (see Attachment A);
Age ≥12 years old
Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;
Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
Initial FEV1 of at least 50% of the normal value estimated.

Key exclusion criteria (8 listed)

Use of oral or parenteral corticosteroids within the last 3 months;
Need of hospitalization due to asthma within the last 3 months;
Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
Recent participation (<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;

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 will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.	Drug	Formoterol/Budesonide
Foraseqformoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.	Drug	Foraseq

Primary outcome

The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
Time frame: 4 months

1 secondary outcome

Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.
Time frame: 4 months

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 19 Mar 2025.

Related trials for ASTHMA

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

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 Formoterol/Budesonide and Foraseq in people with ASTHMA, 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 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 19 Mar 2025. 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?

The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. (time frame: 4 months). 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 NCT01001364.

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 19 Mar 2025.