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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Foster 100/6mg NEXThaler; Drug: Foster 100/6mg pMDI

• Registration Number: NCT03453112
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-09
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-05
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Trial Locations

Locations (50)

Chiesi Clinical Trial site 15670; 🇨🇳 Guizhou, China

Chiesi Clinical Trial site 15641; 🇨🇳 Hefei, Anhui, China

Chiesi clinical Trial site 15656; 🇨🇳 Guangzhou, Guangdong, China

Chiesi Clinical Trial site 15682; 🇨🇳 Beijing, Beijing, China

Chiesi clinical Trial Site 15610; 🇨🇳 Guangzhou, Guangdong, China

Chiesi Clinical Trial site 15677; 🇨🇳 Huizhou, Guangdong, China

Chiesi Clinical Trial site 15608; 🇨🇳 Shenzhen, Guangdong, China

Chiesi Clinical Trial site 15610; 🇨🇳 Guangzhou, Guangzhou, China

Chiesi Clinical Trial site 15673; 🇨🇳 Haikou, Hainan, China

Chiesi Clinical Trial site 15683; 🇨🇳 Shenzhen, Guangdong, China

Chiesi Clinical Trial site 15678; 🇨🇳 Qiqihar, Heilongjiang, China

Chiesi Clinical Trial site 15681; 🇨🇳 Xinxiang, Henan, China

Chiesi Clinical Trial site 15614; 🇨🇳 Wuhan, Hubei, China

Chiesi Clinical Trial site 15661; 🇨🇳 Wuhan, Hubei, China

Chiesi Clinical Trial site 15643; 🇨🇳 Changzhou, Jiangsu, China

Chiesi Clinical Trial site 15674; 🇨🇳 Pingxiang, Jiangxi, China

Chiesi Clinical Trial site 15676; 🇨🇳 Jilin, Jilin, China

Chiesi Clinical Trial site 15650; 🇨🇳 Hohhot, Neimenggu, China

Chiesi clinical Trial site 15659; 🇨🇳 Hohhot, Neimenggu, China

Chiesi Clinical Trial site 15625; 🇨🇳 Taiyuan, Shan XI Province, China

Chiesi Clinical Trial site 15664; 🇨🇳 Shanghai, Shanghai, China

Chiesi clinical Trial site 15621; 🇨🇳 Shenyang, Liaoning, China

Chiesi Clinical Trial site 15631; 🇨🇳 Shanghai, Shanghai, China

Chiesi Clinical Trial site 15611; 🇨🇳 Shijiazhuang, Shijiazhuang, China

Chiesi Clinical Trial site 15680; 🇨🇳 Chongqing, Sichuan, China

Chiesi Clinical Trial site 15663; 🇨🇳 Beijing, Beijing, China

Chiesi Clinical Trial site 15671; 🇨🇳 Guangzhou, Guangdong, China

Chiesi Clinical Trial site 15662; 🇨🇳 Foshan, Guangdong, China

Chiesi Clinical Trial site 15668; 🇨🇳 Guangzhou, Guangzhou, China

Chiesi Clinical Trial site 15607; 🇨🇳 Zhanjiang, Guangdong, China

Chiesi Clinical Trial site 15679; 🇨🇳 Zhengzhou, Henan, China

Chiesi Clinical Trial site 15675; 🇨🇳 Hengyang, Hunan, China

Chiesi clinical Trial site 15619; 🇨🇳 Nanchang, Nanchang, China

Chiesi Clinical Trial site 15630; 🇨🇳 Shanghai, Shanghai, China

Chiesi Clinical Trial site 15654; 🇨🇳 Shanghai, Shanghai, China

Chiesi Clinical Trial site 15665; 🇨🇳 Shanghai, Shanghai, China

Chiesi Clinical Trial site 15633; 🇨🇳 Chengdu, Sichuan, China

Chiesi Clinical Trial site 15642; 🇨🇳 Tianjin, Tianjin, China

Chiesi Clinical Trial site 15634; 🇨🇳 Tianjin, Tianjin, China

Chiesi Clinical Trial site 15626; 🇨🇳 Xian, Xian, China

Chiesi Clinical Trial site 15638; 🇨🇳 Chongqing, China

Chiesi clinical Trial site 15636; 🇨🇳 Beijing, China

Chiesi Clinical Trial site 15672; 🇨🇳 Beijing, China

Chiesi clinical Trial Site 15611; 🇨🇳 Hebei, China

Chiesi Clinical trial site 15660; 🇨🇳 Jilin, China

Chiesi Clinical Trial site 15628; 🇨🇳 Shanghai, China

Chiesi clinical trial site 15637; 🇨🇳 Shanghai, China

Chiesi Clinical Trial site 15666; 🇨🇳 Shenzhen, China

Chiesi clinical Trial site 15633; 🇨🇳 Sichuan, China

Chiesi Clinical Trial site 15669; 🇨🇳 Ürümqi, China