Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLAMBOYANT 125/12 | Experimental | The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Flamboyant 125/12 capsule 1 Budesonide/formoterol 200/6 Placebo capsule. |
|
| Budesonide/formoterol 200/6 | Active Comparator | The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Budesonide/formoterol 200/6 capsule 1 Flamboyant 125/12 Placebo capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flamboyant 125/12 | Drug | Flamboyant 125/12 capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events recorded during the study. | 14 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Dumont Alves, MD | Contact | +551938879851 | pesquisa.clinica@ncfarma.com.br |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Pesquisa Clínica | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind and double-dummy
| Budesonide/formoterol 200/6 |
| Drug |
Budesonid/formoterol 200/6 capsule |
|
| Flamboyant 125/12 Placebo | Other | Flamboyant 125/12 Placebo capsule |
|
| Budesonide/formoterol 200/6 placebo | Other | Budesonid/formoterol 200/6 Placebo capsule |
|
| IMC Tatuí | Recruiting | Tatuí | São Paulo | Brazil |
| CPCLin | Recruiting | São Paulo | Brazil |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |