Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02155881
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2014-06-02
Brief Title:
Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis SAR in Russia
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-Center Double-Blind Placebo-Controlled Two-Arm Parallel-Group Phase III Registration Study to Assess the Efficacy and Safety of Ciclesonide Nasal Spray Omnaris 200 mcg Once Daily in the Treatment of the Patients With Seasonal Allergic Rhinitis SAR in Russia
Status:
COMPLETED
Status Verified Date:
2016-12
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 study is to explore the efficacy and safety of Ciclesonide Nasal Spray 200 microgram mcg once daily in the treatment of seasonal allergic rhinitis SAR in Russian participants
Detailed Description:
The drug being tested in this study is called ciclesonide Ciclesonide is being tested to treat allergy symptoms in people who have SAR This study will look at improvement of allergy symptoms in Russian participants who take ciclesonide nasal spray
The study will enroll approximately 80 participants Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need
Ciclesonide nasal spray 200 mcg
Placebo nasal spray dummy inactive nasal spray - this is a nasal spray that looks like the study drug but has no active ingredient
All participants will be asked to take 2 actuations per nostril at the same time each day throughout the study and will be asked to record the severity of their allergy symptoms twice a day in a diary
This multi-centre trial will be conducted in Russia The overall time to participate in this study is up to 5 weeks Participants will make 3 visits to the clinic and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 80 participants Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need
Ciclesonide nasal spray 200 mcg
Placebo nasal spray dummy inactive nasal spray - this is a nasal spray that looks like the study drug but has no active ingredient
All participants will be asked to take 2 actuations per nostril at the same time each day throughout the study and will be asked to record the severity of their allergy symptoms twice a day in a diary
This multi-centre trial will be conducted in Russia The overall time to participate in this study is up to 5 weeks Participants will make 3 visits to the clinic and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment
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 |
|---|---|---|---|
| U1111-1152-9472 | REGISTRY | WHO | None |