Trial Profile
Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 23 Dec 2021
Price :
$35
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At a glance
- Drugs Aclidinium bromide/formoterol (Primary) ; Aclidinium bromide; Formoterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms ACLIFORM; ACLIFORM/COPD
- Sponsors Almirall S.A.
- 17 Apr 2019 According to a Circassia media release, the product is approved worldwide, including in the European Union, under a number of brand names.
- 01 Apr 2019 According to a Circassia media release, the company announces the US Food and Drug Administration (FDA) has approved Duaklir Pressair for the maintenance treatment of chronic obstructive pulmonary disease. The approval is based on a broad clinical database, including data from three phase III studies, ACLIFORM, AUGMENT, AMPLIFY and phase IV ASCENT study.
- 01 Jun 2018 According to a Circassia media release, company announced the submission of a New Drug Application to the United States Food and Drug Administration for Duaklir Pressair for the treatment of chronic obstructive pulmonary disease. The NDA is supported by the data from the AMPLIFY study, results from two previous Duaklir phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.