Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma. (FORTUNE)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Foster 100/6mg pMDI; Drug: Foster 100/6mg NEXThaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT03453112

CCD-01535BA0-01

Details and patient eligibility

About

The purpose of this study is to demonstrate the non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function in asthmatic patients, as well as the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures. The purpose is also to assess the safety and tolerability.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients, Chinese ethnicity aged >18 years with a clinical diagnosis of asthma for a minimum of 6 months prior to visit 1 confirmed by a chest physician according to International guidelines updated 2016 Global Initiative Asthma (GINA).
• Positive Response to Reversibility Test.
• FEV 1 (Forced Expiratory Volume within the first second) >80% of the predicted normal value after appropriate washout from bronchodilators.
• Patients on previous regular treatment at a stable dose for at least 3 months prior to visit 1 with either high daily dose of ICS ( Inhaled Corticosteroids) or medium daily dose of ICS

Exclusion criteria

• Pregnant or lactating woment
• Intermittent asthma or asthma occurring only duting episodic exposure to an allergen or a chemical sensitizer
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Glocal Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines updated 2016
• Current smokers, or ex-smokers
• Severe asthma exacerbation leading to intake of systemic corticosteroids (> 10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbations
• Patients treated with monoclonal antibodies
• Patients treated with non-potassium sparing diuretics
• Patients treated with monoamine oxidase inhibitors and tricyclic antidepressants
• Patients who are receiving therapy that could interact with steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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494 participants in 2 patient groups

Foster 100/6mg NEXThaler

Experimental group

Description:

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler (NEXThaler)

Treatment:

Drug: Foster 100/6mg NEXThaler

Foster 100/6mg pMDI

Active Comparator group

Description:

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.

Treatment:

Drug: Foster 100/6mg pMDI