AsthmaPhase 3NCT01202084
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
A Phase 3 study testing Formoterol/Fluticasone, Foraseq® and Fluticasone in people with Asthma, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers. 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/Fluticasone, Foraseq® and Fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Nov 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
- Age ≥ 12 years
- 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-745 test (see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the predicted normal value
- Serum cortisol assessment within normal values.
Who cannot join
- Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
- Requirement of admission due to asthma within the 3 months prior to study beginning
- Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
- Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
- Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
- Intolerance or allergy to any of the components of the drugs assessed in the study
- Pregnancy or lactation
- Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
About this study
Official title: A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.
- Conditions
- Asthma
- Being tested
- Formoterol/Fluticasone, Foraseq®, Fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol/FluticasoneDrug
Foraseq®Drug
FluticasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Formoterol/Fluticasone Eurofarma | Experimental | formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks Receives: Drug: Formoterol/Fluticasone |
| Foraseq® | Active comparator | formoterol + budedonide (12/400 mcg) twice a day per 12 weeks Receives: Drug: Foraseq® |
| Fluticasone | Active comparator | fluticasone (500 mcg) twice a day per 12 weeks Receives: Drug: Fluticasone |
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 final visit.
Measured: 12 weeks
Secondary outcomes (1)
Peak expiratory flow (PEF)
Measured: 12 weeks
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 startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 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
- NCT01202084
- Sponsor's protocol ID
- EF 065
- Other IDs
- CAINAS FF
- Status last verified
- May 2012
- First submitted
- 14 Sep 2010
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
- ClinicalTrials.gov ID
- NCT01202084
- Acronym / sponsor ID
- EF 065
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 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 impact of the study formulations on pulmonary function in persistent asthma carriers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formoterol/Fluticasone Eurofarma | Experimental | Drug: Formoterol/Fluticasoneformoterol + fluticasone (12/250 mcg) twice a day per 12 weeks |
| Foraseq® | Active comparator | Drug: Foraseq®formoterol + budedonide (12/400 mcg) twice a day per 12 weeks |
| Fluticasone | Active comparator | Drug: Fluticasonefluticasone (500 mcg) twice a day per 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
- Age ≥ 12 years
- 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-745 test (see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the predicted normal value
Key exclusion criteria (8 listed)
- Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
- Requirement of admission due to asthma within the 3 months prior to study beginning
- Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
- Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
- Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating 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/Fluticasone | Drug | Formoterol/Fluticasone Eurofarma |
| Foraseq® | Drug | Foraseq® |
| Fluticasone | Drug | Fluticasone |
Primary outcome
Forced expiratory volume in 1 second (FEV1) at final visit.
Time frame: 12 weeks
1 secondary outcome
Peak expiratory flow (PEF)
Time frame: 12 weeks
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 18 Jun 2015.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
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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 Formoterol/Fluticasone, Foraseq® and Fluticasone 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 18 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 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 final visit. (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 NCT01202084, 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 18 Jun 2015.