Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497523
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2007-07-04
Brief Title:
Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed SalbutamolBeclomethasone Fixed Combination in Young Children With Asthma Symptoms
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
Double Blind Multinational Multicentre Parallel-group Placebo-controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate 400 μg bid Plus as Needed Salbutamol Versus as Needed Salbutamol or as Needed SalbutamolBeclomethasone Fixed Combination in the 12-week Treatment of Young Children With Asthma Symptoms
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:
To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation compared to placebo plus rescue salbutamol in the relief of symptoms of asthma in young children with persistent symptoms of asthma
Detailed Description:
Asthma is a chronic disease which is estimated to affect over 25 million people both in the US and Europeie approximately 10 of the total populationThere is evidence that over the last 20 years prevalence has considerably increased especially among children The diagnosis of asthma in children may be difficult largely because episodic wheezing and cough are among the common symptoms encountered in childhood illnesses particularly in children under 3 years oldAlthough in these young children there is the possibility of over treatment the episodes of wheezing may be reduced in intensity by the effective use of anti-inflammatory medications and bronchodilators rather than antibiotics At present pharmacological therapy is used to treat reversible airway obstruction inflammation and hyperreactivity in both children and adults Medications include preventive treatments in forms of antinflammatoryantiallergic agents eg glucocorticosteroids leukotriene antagonists cromolyn sodium and reliever treatments in form of bronchodilators eg β-adrenergic agonists anticholinergics Comparisons Beclomethasone suspension for nebulisation 400 mcg UDV plus as needed salbutamol compared to placebo plus as needed salbutamol and to as needed salbutamolbeclomethasone fixed combination
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