Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403637
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-11-06
Brief Title:
Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler SDDPI Compared to Placebo in Patients With Persistent Asthma
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Double-dummy Active Formoterol 12 µg bid and Placebo Controlled Multi-center 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler SDDPI vs Placebo in Patients With Persistent Asthma
Status:
COMPLETED
Status Verified Date:
2016-11
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 is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma All patients will receive 1 day of treatment with each of the following indacaterol 150 µg indacaterol 300 µg indacaterol 600 µg placebo and formoterol Each treatment day will be followed by a washout-period of 1 week
Detailed Description:
None
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