• 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 » Duaklir Pressair (aclidinium bromide and formoterol fumarate)

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

Duaklir Pressair (aclidinium bromide and formoterol fumarate)

  • Profile

Profile

Contact Information

Contact: AstraZeneca
Website: www.astrazeneca.com

Currently Enrolling Trials

    Show More

    General Information

    Duaklir Pressair is a combination of aclidinium bromide, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA).

    Duaklir Pressair is specifically indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 

    Duaklir Pressair is supplied as an inhalation powder, for oral inhalation. The recommended dose of Duaklir Pressair is one oral inhalation of 400 mcg/12 mcg, twice daily (once in the morning and once in the evening). Do not take more than one inhalation twice daily.

    Mechanism of Action

    Duaklir Pressair is a combination of aclidinium bromide, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA).

    Aclidinium bromide is a long-acting antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.

    Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (LABA) (beta2agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

    Side Effects

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

    • upper respiratory tract infection
    • headache
    • back pain

    Clinical Trial Results

    The FDA approval of Duaklir Pressiar was based on a clinical development program that included three dose ranging trials, one active and two placebo-controlled lung function trials of 24 weeks duration; and one 28-week long-term safety extension study. The efficacy of Duaklir was primarily based on one dose ranging trial in 128 subjects with COPD and the three 6-month duration confirmatory trials in 5015 subjects with COPD, including chronic bronchitis and emphysema.

    Dose-Ranging Trials

    Dose selection for Duaklir Pressair for COPD was primarily based on data for the individual components, aclidinium bromide and formoterol fumarate, in COPD patients.

    Aclidinium: Dose selection for aclidinium was supported by a 7-day, randomized, double-blind, active and placebo-controlled, crossover trial evaluating 3 doses of aclidinium bromide(400, 200,and 100 mcg) administered twice daily and an active control in 79 subjects with COPD. A dose ordering was observed, with the aclidinium bromide 400 mcg demonstrating larger improvements in FEV1 over 24 hours compared with aclidinium bromide 200 mcg and 100 mcg. The change from baseline in FEV1 AUC0-12 from placebo after 7 days for the 100, 200, and 400 mcg doses were 154 mL, 176 mL and 208 mL, respectively. The results supported the selection of 400 mcg of aclidinium bromide twice daily in the confirmatory COPD trials.

    Formoterol: Dose selection for formoterol was supported by a randomized, double-blind, placebo and active comparator (open-label) controlled, 5-period incomplete unbalanced crossover trial evaluating 3 doses of formoterol fumarate (24, 12, and 6 mcg) administered twice daily and an open-label active comparator in 132 subjects with COPD. The change from baseline in FEV1 AUC0-12 from placebo after 7 days for the 6, 12, and 24 mcg doses were 108 mL, 117 mL, and 162 mL, respectively. The results supported the evaluation of 12 mcg of formoterol twice daily in the confirmatory COPD trials.

    Confirmatory Trials

    The clinical development program for Duaklir Pressair included two placebo-controlled (Trial 1) and Trial 2 and one active-controlled (Trial 3) randomized, double-blind, parallel-group 24-week trials in subjects with moderate to very severe COPD, including chronic bronchitis and emphysema, designed to evaluate the efficacy of Duaklir Pressair on lung function. The 24-week trials included 4,977 subjects >40 years of age that had a clinical diagnosis of COPD, with a smoking history greater than or equal to 10 pack-years, a post-albuterol FEV1 less than 80% of predicted normal values, and a ratio of FEV1/FVC of less than 0.7. The majority of these patients were male (61%) and Caucasian (94%) with a mean age of 64 years and an average smoking history of 46 pack-years (50% current smokers). Trials 1, 2, and 3 evaluated Duaklir  Pressair (aclidinium/formoterol fumarate) 400 mcg/12 mcg, aclidinium 400 mcg, and formoterol fumarate 12 mcg. Trials 1 and 2 included a placebo arm, and Trial 3 included an active, blinded, control arm.
    The co-primary endpoints were change from baseline in trough FEV1 and change from baseline in one-hour post-dose FEV1 at Week 24 compared with formoterol fumarate 12 mcg and aclidinium 400 mcg, respectively. In the three trials, Duaklir Pressair demonstrated a statistically significant increase in mean change from baseline in trough FEV1 and change from baseline in one-hour post-dose FEV1 at Week 24 relative to formoterol fumarate 12mcg and aclidinium 400 mcg, respectively.

    Approval Date: 2019-04-01
    Company Name: AstraZeneca
    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