Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-28 @ 1:40 AM
Study NCT ID:
NCT05588804
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2022-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections
Sponsor:
Sandoz
Organization:
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Comparative Multicenter Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg (Sandoz dd, Slovenia) in the Treatment of Patients With Acute Uncomplicated Respiratory Tract Infections
Status:
COMPLETED
Status Verified Date:
2023-08
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 study will evaluate the efficacy and safety of Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia) versus Placebo in the treatment of patients with acute uncomplicated respiratory tract infections.
Detailed Description:
Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomized into 2 groups in a 1: 1 ratio.
Group 1 (n = 278) will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia),
Group 2 (n = 278) will receive a placebo
Group 1 (n = 278) will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia),
Group 2 (n = 278) will receive a placebo
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: