Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413387
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2006-12-18
Brief Title:
Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg Formoterol 6 µg pMDI Via HFA-134a Vs Budesonide 160 µg Formoterol 45 µg Dry Powder Via Turbuhaler Symbicort
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
Double Blind Double Dummy Multinational Multicentre Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 Beclomethasone Dipropionate 100 µg Formoterol 6 µg pMDI Via HFA-134a Vs Budesonide 160 µg Formoterol 45 µg Dry Powder Via Turbuhaler Symbicort in the 12-Week Treatment of Adult Patients With Moderate to Severe Persistent Asthma
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasoneformoterol pMDI with that of budesonideformoterol dry powder via Turbuhaler
Detailed Description:
Asthma is a chronic disease that is estimated to affect over 25 million people both in the US and in Europe ie approximately 10 of the total population Pharmacological therapy is used to treat reversible airway obstruction inflammation and hyper-reactivity Medications include preventive treatments in forms of antinflammatoryantiallergic agents ie glucocorticosteroids leukotriene antagonists cromolyn sodium and reliever treatments in forms of bronchodilators ie β-adrenergic agonists anticholinergics In patients treated with inhaled glucocorticosteroids whose asthma is not fully controlled national and international guidelines recommend a stepwise approach Recent evidence-based clinical trials show that the addition of a LABA to inhaled glucocorticosteroids is more beneficial in terms of asthma control than increasing the dose of corticosteroids alone
COMPARISONS CHF 1535 BECLOMETHASONE DIPROPIONATE 100 µg FORMOTEROL 6 µg pMDI via HFA-134a compared to SYMBICORT BUDESONIDE 160 µg FORMOTEROL 45 µg
COMPARISONS CHF 1535 BECLOMETHASONE DIPROPIONATE 100 µg FORMOTEROL 6 µg pMDI via HFA-134a compared to SYMBICORT BUDESONIDE 160 µg FORMOTEROL 45 µg
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