Asthma
Conditions
Brief 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' compliance to the treatment.
Detailed description
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.
Interventions
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
DRUGForaseq
foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
DRUGAlenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups | 12 weeks | 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 154 |
| Foraseq 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. | 145 |
| 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. | 151 |
| Total | 450 |
Baseline characteristics
| Characteristic | Foraseq | Alenia | Formoterol/Budesonide | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 21 Participants | 28 Participants | 74 Participants |
| Age, Categorical >=65 years | 8 Participants | 9 Participants | 7 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 121 Participants | 119 Participants | 352 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 17 | 39 years STANDARD_DEVIATION 16 | 38 years STANDARD_DEVIATION 17 | 39 years STANDARD_DEVIATION 17 |
| Region of Enrollment Brazil | 145 participants | 151 participants | 154 participants | 450 participants |
| Sex: Female, Male Female | 99 Participants | 110 Participants | 99 Participants | 308 Participants |
| Sex: Female, Male Male | 46 Participants | 41 Participants | 55 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 154 | 0 / 145 | 0 / 151 |
| serious Total, serious adverse events | 1 / 154 | 0 / 145 | 0 / 151 |
Outcome results
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
Time frame: 12 weeks
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formoterol/Budesonide | Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV) | 2.53 Liter | Standard Deviation 0.79 |
| Alenia | Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV) | 2.51 Liter | Standard Deviation 0.77 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formoterol/Budesonide | FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups | 2.49 Liter | Standard Deviation 0.77 |
| Alenia | FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups | 2.52 Liter | Standard Deviation 0.8 |
| Foraseq | FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups | 2.46 Liter | Standard Deviation 0.88 |