Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528723
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2007-09-11
Brief Title:
Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
Multicentre Multinational Randomised Double Blind Double Dummy Active Drug Controlled Parallel Group Study Design Clinical Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate 250 mcg Plus Salbutamol 100 mcg in HFA pMDI Fixed Combination vs Beclomethasone Dipropionate 250 mcg Plus Salbutamol 100 mcg in CFC pMDI Clenil Compositum 250 Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Status:
COMPLETED
Status Verified Date:
2017-03
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 purpose of this trial is to verify if the test treatment BDP 250 mcgsalbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcgsalbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant Clenil Compositum 250 Chiesi Farmaceutici in terms of Pulmonary Function morning PEF
Detailed Description:
Asthma is a chronic inflammatory disorder of the airways and a serious public health worldwide problem affecting people of all ages with an estimate of 300 millions affected individualsWhen uncontrolled asthma can place severe limits on daily life and can sometimes be fatal
There are two major classes of inhaled therapy for the treatment of reversible obstructive airways disease antinflammatory agents and bronchodilators In particular BDP 250 mcg plus salbutamol 100 mcg in fixed combination is an effective and safe method to control symptoms of persistent asthma in adults
This study has been designed to compare the efficacy safety and tolerability of a new BDP 250 mcgsalbutamol 100 mcg HFA pMDI fixed combination with the same CFC-formulated fixed combination which is on the market from some decadesThe HFA propelled product is developed to replace the CFC formulation already marketed according to the European Unions Committee for Proprietary Medicinal Products CPMP Note for Guidance III537893 - Final in order to prevent from depletion of stratospheric ozone
The primary objective of this trial is to demonstrate that the test treatment BDP 250 mcgsalbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcgsalbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant Clenil Compositum 250 Chiesi Farmaceutici in terms of Pulmonary Function morning PEF
Given the aim of the study the population to be monitored includes adult patients with persistent asthma according to the current guidelines The treatment period will be preceded by a 2-week run-in period Subjects satisfying all the inclusion and exclusion criteria will then enter the 12-week treatment period Clinic visits will take place at the start and end of the run-in period and after 2 4 8 and 12 weeks after randomisation
There are two major classes of inhaled therapy for the treatment of reversible obstructive airways disease antinflammatory agents and bronchodilators In particular BDP 250 mcg plus salbutamol 100 mcg in fixed combination is an effective and safe method to control symptoms of persistent asthma in adults
This study has been designed to compare the efficacy safety and tolerability of a new BDP 250 mcgsalbutamol 100 mcg HFA pMDI fixed combination with the same CFC-formulated fixed combination which is on the market from some decadesThe HFA propelled product is developed to replace the CFC formulation already marketed according to the European Unions Committee for Proprietary Medicinal Products CPMP Note for Guidance III537893 - Final in order to prevent from depletion of stratospheric ozone
The primary objective of this trial is to demonstrate that the test treatment BDP 250 mcgsalbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcgsalbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant Clenil Compositum 250 Chiesi Farmaceutici in terms of Pulmonary Function morning PEF
Given the aim of the study the population to be monitored includes adult patients with persistent asthma according to the current guidelines The treatment period will be preceded by a 2-week run-in period Subjects satisfying all the inclusion and exclusion criteria will then enter the 12-week treatment period Clinic visits will take place at the start and end of the run-in period and after 2 4 8 and 12 weeks after randomisation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-002816-25 | EUDRACT_NUMBER | None | None |