• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Utibron Neohaler (indacaterol and glycopyrrolate)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Utibron Neohaler (indacaterol and glycopyrrolate)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Utibron Neohaler is a fixed dose combination of glycopyrronium bromide, a once-daily long-acting muscarinic antagonist, and indacaterol, a once-daily long-acting beta-2 agonist.

    Utibron Neohaler is specifically indicated for the long term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

    Utibron Neohaler is supplied as an inhalation powder, for oral inhalation use. The recommended dose is the inhalation of the contents of one Utibron capsule twice daily using the Neohaler device. Utibron Neohaler should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 capsule twicedaily) is not recommended

    Clinical Results

    FDA Approval

    The FDA approval of Utibron Neohaler was based on results of the phase III EXPEDITION trial program, which included 2,654 patients with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2) and one 52-week safety study (FLIGHT 3). In the efficacy studies, Utibron Neohaler demonstrated superior and sustained improvements in lung function (FEV1 AUC0-12) at week 12, compared to its individual bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo, all dosed twice-daily. Improvements in lung function were seen compared to placebo at 5 minutes after the first dose and sustained through the 12 hour dosing interval. Utibron Neohaler also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo.

    Side Effects

    Adverse effects associated with the use of Utibron Neohaler may include, but are not limited to, the following:

    • nasopharyngitis
    • hypertension

    Utibron Neohaler comes with a black box warning of the potential for long-acting beta2-adrenergic agonists (LABAs) to increase the risk of asthma-related death.

    Mechanism of Action

    Utibron Neohaler is a fixed dose combination of glycopyrronium bromide, a once-daily long-acting muscarinic antagonist, and indacaterol, a once-daily long-acting beta-2 agonist.

    Additional Information

    For additional information regarding Utibron Neohaler or the long term, maintenance treatment of airflow obstruction in patients with COPD, please visit http://www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf

    Approval Date: 2015-10-01
    Company Name: Novartis
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing