Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01001364
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2009-10-23
Brief Title:
A Comparative Study Between Foraseq And FormoterolBudesonide Inhalation Capsules in Patients With Asthma
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Phase III Randomized Open-Label Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12200 µg And Formoterol Budesonide Inhalation Capsules 12200 µg Eurofarma In Patients With Asthma
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAINAS
Brief Summary:
This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma
Detailed Description:
This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma This is a non-inferiority study which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end Therefore the study primary endpoint will be the forced expiratory volume in 1 second FEV1 at the final visit FV at each study arm
This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma
The secondary endpoints considered for this study are
Score of asthma control questionnaire ACQ-7 34 at the end of the study
Peak of expiratory flow PEF throughout the study
Symptoms score at the end of the study
FEV1 throughout the study
Treatment safety including serum cortisol dosage
Frequency of observed adverse events
Some eligibility criteria
Current use of inhaled corticosteroids equivalent to beclometasone dipropionate 1000µg associated or not to long-acting β2-adrenergics and relief medication salbutamol or equivalent
Diagnosis of mild to moderate persistent asthma as per the ARIA classification 35 with symptoms for at least 6 months clinically stable for at least 1 month with ACQ-7 test34 see Attachment D 30
This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma
The secondary endpoints considered for this study are
Score of asthma control questionnaire ACQ-7 34 at the end of the study
Peak of expiratory flow PEF throughout the study
Symptoms score at the end of the study
FEV1 throughout the study
Treatment safety including serum cortisol dosage
Frequency of observed adverse events
Some eligibility criteria
Current use of inhaled corticosteroids equivalent to beclometasone dipropionate 1000µg associated or not to long-acting β2-adrenergics and relief medication salbutamol or equivalent
Diagnosis of mild to moderate persistent asthma as per the ARIA classification 35 with symptoms for at least 6 months clinically stable for at least 1 month with ACQ-7 test34 see Attachment D 30
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None