Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382889
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2006-09-29
Brief Title:
As Needed BeclomethasoneSalbutamol Combination in Single Inhaler for Mild Persistent Asthma
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
Multinational Double Blind Randomised Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate 250 mg Combined With Salbutamol 100 mg in the Treatment of Patients With Mild 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 is to reveal that inhaled corticosteroid therapy combined with a short-acting beta2- agonist given on a symptom driven basis is as effective as traditional asthma therapy
Thus three advantages will be achieved
1 better compliance with treatment since patients will most likely have to administer the treatment less frequently
2 maximum pharmacological effect with the least amount of drug and
3 less economic burden on health care providers
Thus three advantages will be achieved
1 better compliance with treatment since patients will most likely have to administer the treatment less frequently
2 maximum pharmacological effect with the least amount of drug and
3 less economic burden on health care providers
Detailed Description:
Asthma is widely recognised as a chronic inflammatory disorder of the airways The 1997 American National Heart Lung and Blood Institute NHLBI Guidelines states that a firm scientific basis exists to indicate that asthma results from complex interactions among inflammatory cells mediators and the cells and tissues resident in the airways
Despite the existence of effective therapy people still die from asthma It is pertinent to state that the clinical effect of a drug is not only dependent on the specific action of the drug but also on the patients way of using it Therefore compliance is an important factor especially for chronic disorders such as asthma Indeed non compliance with asthma therapy is a serious problem It has been reported that drug side effects lifestyle social and economic factors method of drug delivery and dosing are factors that contribute to poor compliance The consequences of poor compliance lead to increased morbidity due to increased symptoms and asthma exacerbation
The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with inhaled glucocorticoids 200-500mcgdie and short-acting bronchodilators as needed but no more than 3-4 times a day
Comparisons beclomethasone dipropionate 250 mg combined with salbutamol 100 mg as needed vs salbutamol 100 mg alone as needed vs beclomethasone 250 mg twice a day plus salbutamol 100 mg as needed and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg twice a day plus salbutamol 100 mg as needed in the treatment of patients with mild persistent asthma
Despite the existence of effective therapy people still die from asthma It is pertinent to state that the clinical effect of a drug is not only dependent on the specific action of the drug but also on the patients way of using it Therefore compliance is an important factor especially for chronic disorders such as asthma Indeed non compliance with asthma therapy is a serious problem It has been reported that drug side effects lifestyle social and economic factors method of drug delivery and dosing are factors that contribute to poor compliance The consequences of poor compliance lead to increased morbidity due to increased symptoms and asthma exacerbation
The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with inhaled glucocorticoids 200-500mcgdie and short-acting bronchodilators as needed but no more than 3-4 times a day
Comparisons beclomethasone dipropionate 250 mg combined with salbutamol 100 mg as needed vs salbutamol 100 mg alone as needed vs beclomethasone 250 mg twice a day plus salbutamol 100 mg as needed and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg twice a day plus salbutamol 100 mg as needed in the treatment of patients with mild persistent asthma
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