A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (ESPIRE)
Primary Purpose
Asthma Copd
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma Copd
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 12 years
- Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.
Exclusion Criteria:
- Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
- Presence of acute or chronic symptomatic airway infection.
Sites / Locations
- Eurofarma Laboratorios S.ARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg)
Alenia® (12/400mcg e 6/200mcg)
Arm Description
Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Outcomes
Primary Outcome Measures
FEV1
Average change from baseline in pre-dose Forced Expiratory Volume in one second
Secondary Outcome Measures
Full Information
NCT ID
NCT04233190
First Posted
January 15, 2020
Last Updated
May 4, 2023
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04233190
Brief Title
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
Acronym
ESPIRE
Official Title
A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD).
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Detailed Description
In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes the potential bias arising from the open label of the study.
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Copd
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
472 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg)
Arm Type
Experimental
Arm Description
Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg
Arm Title
Alenia® (12/400mcg e 6/200mcg)
Arm Type
Active Comparator
Arm Description
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Intervention Type
Drug
Intervention Name(s)
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Other Intervention Name(s)
fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg
Intervention Description
one inhalation, twice daily
Primary Outcome Measure Information:
Title
FEV1
Description
Average change from baseline in pre-dose Forced Expiratory Volume in one second
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 12 years
Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.
Exclusion Criteria:
Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
Presence of acute or chronic symptomatic airway infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edilene Macedo
Phone
+55 11 50908422
Email
edilene.macedo@eurofarma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Gianni
Phone
41449500
Email
natalia.gianni@eurofarma.com
Facility Information:
Facility Name
Eurofarma Laboratorios S.A
City
São Paulo
ZIP/Postal Code
06696-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edilene Macedo
Phone
55 11 50908600
Ext
8422
Email
edilene.macedo@eurofarma.com
First Name & Middle Initial & Last Name & Degree
Natalia Gianni
Phone
41449500
Email
natalia.gianni@eurofarma.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
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