Trial Outcomes & Findings for A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma (NCT NCT01167010)
NCT ID: NCT01167010
Last Updated: 2025-05-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
552 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-05-01
Participant Flow
Participant milestones
| Measure |
Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Foraseq
Foraseq will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Alenia
Alenia will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
184
|
184
|
184
|
|
Overall Study
COMPLETED
|
154
|
145
|
151
|
|
Overall Study
NOT COMPLETED
|
30
|
39
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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).
Baseline characteristics by cohort
| Measure |
Formoterol/Budesonide
n=154 Participants
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.
|
Foraseq
n=145 Participants
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.
|
Alenia
n=151 Participants
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.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
352 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 17 • n=5 Participants
|
39 years
STANDARD_DEVIATION 17 • n=7 Participants
|
39 years
STANDARD_DEVIATION 16 • n=5 Participants
|
39 years
STANDARD_DEVIATION 17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants • 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).
|
99 Participants
n=7 Participants • 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).
|
110 Participants
n=5 Participants • 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).
|
308 Participants
n=4 Participants • 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).
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants • 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).
|
46 Participants
n=7 Participants • 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).
|
41 Participants
n=5 Participants • 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).
|
142 Participants
n=4 Participants • 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).
|
|
Region of Enrollment
Brazil
|
154 participants
n=5 Participants
|
145 participants
n=7 Participants
|
151 participants
n=5 Participants
|
450 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
Formoterol/Budesonide
n=154 Participants
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Alenia
n=150 Participants
Alenia 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.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
|
2.53 Liter
Standard Deviation 0.79
|
2.51 Liter
Standard Deviation 0.77
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Formoterol/Budesonide
n=150 Participants
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Alenia
n=154 Participants
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
Foraseq
n=145 Participants
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
|---|---|---|---|
|
FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups
|
2.49 Liter
Standard Deviation 0.77
|
2.52 Liter
Standard Deviation 0.80
|
2.46 Liter
Standard Deviation 0.88
|
Adverse Events
Formoterol/Budesonide
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Foraseq
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alenia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Formoterol/Budesonide
n=154 participants at risk
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Foraseq
n=145 participants at risk
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
Alenia
n=151 participants at risk
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/154 • Number of events 1
|
0.00%
0/145
|
0.00%
0/151
|
|
Immune system disorders
Leukopenia
|
0.65%
1/154 • Number of events 1
|
0.00%
0/145
|
0.00%
0/151
|
Other adverse events
| Measure |
Formoterol/Budesonide
n=154 participants at risk
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
|
Foraseq
n=145 participants at risk
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
Alenia
n=151 participants at risk
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Left and posterior knee trauma infection
|
0.65%
1/154 • Number of events 1
|
0.00%
0/145
|
0.00%
0/151
|
Additional Information
Sandra Rodrigues (Clinical Research)
Eurofarma Laboratórios S.A
Phone: 1150908600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER