AsthmaPhase 3CAINAS SFNCT01202097
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma
A Phase 3 study testing Salmeterol/Fluticasone and Seretide in people with Asthma, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
Trial summary
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol/Fluticasone and Seretide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 6 sitesBrazil
- Study dates
- Aug 2011to May 2012
- 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 the ICF
- ≥ 12 years old
- Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the normal value expected
- Blood cortisol evaluation within the normal limits.
Who cannot join
- Use of oral or parenteral corticosteroid within the last 3 previous months to the study
- Hospitalization needed due to asthma within the last 3 previous months to 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 severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
- Recent (<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - 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
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital de Clinicas UFPR
Curitiba, PR
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, BA
Centro de Estudos de Pneumologia FMABC
São Paulo
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
Stelmach Pesquisa Clinica
São Paulo
Clinica de Alergia Martti Antila
Sorocaba, SP
About this study
Official title: A PHASE III, RANDOMIZED, OPEN-LABEL, NON-INFERIORITY COMPARATIVE STUDY BETWEEN SERETIDE® 50/250 ΜG and SALMETEROL/FLUTICASONE SINGLE INHALATION CAPSULE 50/250 ΜG EUROFARMA in PATIENTS with ASTHMA
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
Read the detailed description
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit.
Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.
- Conditions
- Asthma
- Being tested
- Salmeterol/Fluticasone, Seretide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/FluticasoneDrug
SeretideDrug
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol/Fluticasone | Experimental | Not described Receives: Drug: Salmeterol/Fluticasone |
| Seretide | Active comparator | Not described Receives: Drug: Seretide |
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.
Secondary outcomes (1)
Expiratory Flow Peak (EFP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startAug 2011
- Study completionMay 2012
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
- 334 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
- NCT01202097
- Sponsor's protocol ID
- EF113
- Acronym
- CAINAS SF
- Status last verified
- Sep 2010
- First submitted
- 14 Sep 2010
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 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 SERETIDE® 50/250 ΜG and SALMETEROL/FLUTICASONE SINGLE INHALATION CAPSULE 50/250 ΜG EUROFARMA in PATIENTS with ASTHMA
- ClinicalTrials.gov ID
- NCT01202097
- Acronym / sponsor ID
- CAINAS SF / EF113
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Study completion
- May 2012 (actual)
- First posted
- 15 Sep 2010 (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 primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
Detailed description
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit.
Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmeterol/Fluticasone | Experimental | Drug: Salmeterol/Fluticasone |
| Seretide | Active comparator | Drug: Seretide |
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 persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the normal value expected
Key exclusion criteria (7 listed)
- Use of oral or parenteral corticosteroid within the last 3 previous months to the study
- Hospitalization needed due to asthma within the last 3 previous months to 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 severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
- Recent (<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - Intolerance or allergy to any component of the drugs evaluated in the study
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 |
|---|---|---|
| Salmeterol/Fluticasone | Drug | Salmeterol/Fluticasone |
| Seretide | Drug | Seretide |
Primary outcome
Forced expiratory volume in 1 second (FEV1) at the final visit.
1 secondary outcome
Expiratory Flow Peak (EFP)
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 31 Mar 2025.
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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.
6 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 Salmeterol/Fluticasone and Seretide in people with Asthma, run by Eurofarma Laboratorios S.A. at 6 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 7 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 31 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 6 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?
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 1 second (FEV1) at the final visit.. 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 31 Mar 2025.