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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' compliance to the treatment.
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' compliance to the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formoterol/Budesonide | Experimental | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. |
|
| Foraseq | Active Comparator | Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
|
| Alenia | Active Comparator | Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol/Budesonide | Drug | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Referencia em Enfermidades Respiratoria e Alergica | Salvador | Estado de Bahia | Brazil | |||
| Hospital de Clinicas UFPR |
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| ID | Title | Description |
|---|---|---|
| FG000 | Formoterol/Budesonide | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. |
| FG001 | Foraseq | Foraseq will be administered at the 12/400 µg dosage, twice a day for 12 weeks. |
| FG002 | Alenia | Alenia will be administered at the 12/400 µg dosage, twice a day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Formoterol/Budesonide | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. Formoterol/Budesonide: formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
| BG001 | Foraseq |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | Liter | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol/Budesonide | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Thrombocytopenia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left and posterior knee trauma infection | Injury, poisoning and procedural complications | Left and posterior | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Rodrigues (Clinical Research) | Eurofarma Laboratórios S.A | 1150908600 | 8417 | sandra.rodrigues@eurofarma.com.br |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Foraseq | Drug | foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
|
|
| Alenia | Drug | Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
|
|
| Curitiba |
| Paraná |
| Brazil |
| IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada | São Paulo | São Paulo | Brazil |
| Stelmach Pesquisa Clinica | São Paulo | São Paulo | Brazil |
| Clinica de Alergia Martti Antila | Sorocaba | São Paulo | Brazil |
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. Foraseq: foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
| BG002 | Alenia | Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. Alenia: Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The protocol population (PP) consisted of all patients who adhered to the study procedures and treatment did not violate selection criteria, did not presented other major protocol violations according to the criteria of who had FEV1 data at the final study visit (primary endpoint effectiveness). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
|
| Secondary | 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. | FEV1 (L) measurement at the final study visit (FV) considering the comparison of non-inferiority of Eurofarma research product with Foraseq®, FEV1 (L) of the ITT population. | Posted | Mean | Standard Deviation | Liter | 12 weeks |
|
|
|
| 1 |
| 154 |
| 1 |
| 154 |
| EG001 | Foraseq | Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. | 0 | 145 | 0 | 145 |
| EG002 | Alenia | Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. | 0 | 151 | 0 | 151 |
|
| Leukopenia | Immune system disorders | Systematic Assessment | Leukopenia |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |