Aclidinium bromide

Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD

Retrieved on: 
Tuesday, October 25, 2022

This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD).

Key Points: 
  • This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD).
  • A total of 1,060 patients with moderate to severe stable COPD were included in the trial.
  • Seventy percent of the participants were from China, with other participants coming from Taiwan, India, Vietnam, and the Philippines.
  • Patients were randomized equally to placebo, aclidinium bromide monotherapy (Eklira), aclidinium bromide/formoterol fumarate combination therapy (Duaklir), and monotherapy formoterol for a 24-week period.

Circassia Pharmaceuticals launches DUAKLIR® PRESSAIR® (aclidinium/formoterol) for patients with Chronic Obstructive Pulmonary Disease (COPD)

Retrieved on: 
Monday, October 21, 2019
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20191020005073/en/
    Circassia Pharmaceuticals launches DUAKLIR PRESSAIR (aclidinium/formoterol) for patients with Chronic Obstructive Pulmonary Disease (COPD) (Photo: Business Wire)
    DUAKLIR PRESSAIR is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol.
  • Circassia Pharmaceuticals Inc. is part of the Circassia Pharmaceuticals plc group.
  • In the United States, Circassia markets the chronic obstructive pulmonary disease (COPD) treatments TUDORZA and DUAKLIR.
  • Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial.

Aclidinium is safe and reduces COPD flare-ups, regardless of recent exacerbations

Retrieved on: 
Monday, October 14, 2019

Second, although aclidinium has been shown to be a good bronchodilator, the overall study indicates that it is also effective in reducing exacerbations, which is a pivotal finding.

Key Points: 
  • Second, although aclidinium has been shown to be a good bronchodilator, the overall study indicates that it is also effective in reducing exacerbations, which is a pivotal finding.
  • Most studies of exacerbations include only patients who have had an exacerbation in the preceding year whereas ASCENT included patients both with and without exacerbations.
  • "Prevention of exacerbations of COPD should be a treatment goal in COPD patients regardless of whether they have a history of recent exacerbations," concluded Dr.
  • In the highest risk patients, aclidinium bromide was superior to placebo in reducing exacerbations but did not increase cardiovascular events in high-risk patients.

FDA Approves TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Supplemental New Drug Application (sNDA) to include data for the Reduction of COPD Exacerbations and Hospitalizations

Retrieved on: 
Friday, March 29, 2019

ASCENT showed that TUDORZA PRESSAIR use led to clear and consistent reduction in exacerbations and reductions in flare-ups.

Key Points: 
  • ASCENT showed that TUDORZA PRESSAIR use led to clear and consistent reduction in exacerbations and reductions in flare-ups.
  • The inclusion of the ASCENT safety information in the updated TUDORZA PRESSAIR label addresses that question, said Michael Asmus, Vice President, US Medical Affairs, Circassia.
  • The expanded label for TUDORZA PRESSAIR is welcome news for the COPD community and providers who care for COPD patients, said David Acheson, Senior Vice President, US Commercial, Circassia.
  • Effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with COPD and cardiovascular risk factors.