Sekerel, Bulent Enis
Nell, Haylene
Laki, Istvan
Pak, Tatiana
Contreras, Edgar
Kolarz, Adam
D’Andrea, Peter
Manga, Volkan
Jain, Monish
Vaidya, Soniya
Valentin, Michele
Sen, Biswajit
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study
https://doi.org/10.1007/s40261-023-01300-8
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Accepted: 8 August 2023
First Online: 8 September 2023
Declarations
:
: The study was approved by the independent ethics committee or institutional review boards of each participating center and was conducted in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice and the Declaration of Helsinki. Written informed consent from the parent/legal guardian of pediatric participants and assent by the pediatric patient (depending on local requirements) were obtained.
: Not applicable.
: Novartis is committed to sharing access to patient-level data and supporting documents from eligible studies with qualified external researchers. These requests are reviewed and approved by an independent review panel based on scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
: Not applicable.
: The study was funded by Novartis Pharmaceuticals Corporation, East Hanover.
: BES reports speaker fees from Abbott, Abdi Ibrahim, and Sandoz, outside the submitted work. HN, IL, TP, and EC have nothing to disclose. PD and MV are employees of Novartis Pharmaceutical Corporation, East Hanover. MJ is an employee of Novartis Institutes for BioMedical Research, Cambridge. BS was an employee of Novartis Healthcare Pvt. Ltd, Hyderabad; AK was an employee of Novartis Pharma AG, Basel; VM was an employee of Novartis Pharmaceutical Corporation, East Hanover and SV was an employee of Novartis Institutes for BioMedical Research, Cambridge at the time of study completion.
: The study was designed by SV, PD, VM, and BS. MV, and SV contributed to conduct of these studies. Data were acquired by MV and analyzed by SV, MJ, PD and BS. All authors contributed equally to the interpretation of data. BES is the principal investigator for this study. Data were reviewed by BES, HN, IL, TP, EC, and AK. All authors contributed to intellectual content of the manuscript and approved for publication.