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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Foster 100/6mg NEXThaler	Foster 100/6mg NEXThaler	Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler (NEXThaler)
Foster 100/6mg pMDI	Foster 100/6mg pMDI	Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.

Primary Outcome Measures

Name	Time	Method
Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function	Baseline to week 12	Change from Baseline to the entire treatment period in average pre-dose morning Peek Expiratory flow (PEF)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of the test treatment in terms of additional lung function parameters and clinical outcome measures, and assessement of the safety and tolerability	Baseline to week 12	Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ)

Locations (50): Chiesi Clinical Trial site 15641
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Hefei, Anhui, China
Chiesi Clinical Trial site 15682
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Beijing, Beijing, China
Chiesi Clinical Trial site 15663
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Beijing, Beijing, China
Chiesi Clinical Trial site 15662
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Foshan, Guangdong, China
Chiesi Clinical Trial site 15671
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Guangzhou, Guangdong, China
Chiesi clinical Trial Site 15610
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Guangzhou, Guangdong, China
Chiesi clinical Trial site 15656
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Guangzhou, Guangdong, China
Chiesi Clinical Trial site 15668
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Guangzhou, Guangzhou, China
Chiesi Clinical Trial site 15677
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Huizhou, Guangdong, China
Chiesi Clinical Trial site 15683
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Shenzhen, Guangdong, China
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Chiesi Clinical Trial site 15641
🇨🇳Hefei, Anhui, China