Clinical trial NCT03453112: Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Official title: A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster 100/6mg NEXThaler, 2 Inhalations b.i.d, Versus Foster 100/6mg pMDI, 2 Puffs b.i.d in Patients With Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Peek Expiratory Flow (PEF) Lung function tests
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-03-05
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function
timeFrame: Baseline to week 12
Secondary outcomes:
measure: 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
timeFrame: Baseline to week 12
measure: 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
timeFrame: Baseline to week 12
measure: 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
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Hefei
country: China
facility: Chiesi Clinical Trial site 15641
state: Anhui
city: Beijing
country: China
facility: Chiesi Clinical Trial site 15682
state: Beijing
city: Beijing
country: China
facility: Chiesi Clinical Trial site 15663
state: Beijing
city: Foshan
country: China
facility: Chiesi Clinical Trial site 15662
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi Clinical Trial site 15671
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi clinical Trial Site 15610
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi clinical Trial site 15656
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi Clinical Trial site 15668
state: Guangdong
city: Huizhou
country: China
facility: Chiesi Clinical Trial site 15677
state: Guangdong
city: Shenzhen
country: China
facility: Chiesi Clinical Trial site 15683
state: Guangdong
city: Shenzhen
country: China
facility: Chiesi Clinical Trial site 15608
state: Guangdong
city: Zhanjiang
country: China
facility: Chiesi Clinical Trial site 15607
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi Clinical Trial site 15610
state: Guangzhou
city: Guangzhou
country: China
facility: Chiesi Clinical Trial site 15668
state: Guangzhou
city: Haikou
country: China
facility: Chiesi Clinical Trial site 15673
state: Hainan
city: Qiqihar
country: China
facility: Chiesi Clinical Trial site 15678
state: Heilongjiang
city: Xinxiang
country: China
facility: Chiesi Clinical Trial site 15681
state: Henan
city: Zhengzhou
country: China
facility: Chiesi Clinical Trial site 15679
state: Henan
city: Wuhan
country: China
facility: Chiesi Clinical Trial site 15614
state: Hubei
city: Wuhan
country: China
facility: Chiesi Clinical Trial site 15661
state: Hubei
city: Hengyang
country: China
facility: Chiesi Clinical Trial site 15675
state: Hunan
city: Changzhou
country: China
facility: Chiesi Clinical Trial site 15643
state: Jiangsu
city: Pingxiang
country: China
facility: Chiesi Clinical Trial site 15674
state: Jiangxi
city: Jilin
country: China
facility: Chiesi Clinical Trial site 15676
state: Jilin
city: Shenyang
country: China
facility: Chiesi clinical Trial site 15621
state: Liaoning
city: Nanchang
country: China
facility: Chiesi clinical Trial site 15619
state: Nanchang
city: Hohhot
country: China
facility: Chiesi Clinical Trial site 15650
state: Neimenggu
city: Hohhot
country: China
facility: Chiesi clinical Trial site 15659
state: Neimenggu
city: Taiyuan
country: China
facility: Chiesi Clinical Trial site 15625
state: Shan XI Province
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15630
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15664
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15654
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15630
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15631
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15665
state: Shanghai
city: Shijiazhuang
country: China
facility: Chiesi Clinical Trial site 15611
state: Shijiazhuang
city: Chengdu
country: China
facility: Chiesi Clinical Trial site 15633
state: Sichuan
city: Chongqing
country: China
facility: Chiesi Clinical Trial site 15680
state: Sichuan
city: Tianjin
country: China
facility: Chiesi Clinical Trial site 15642
state: Tianjin
city: Tianjin
country: China
facility: Chiesi Clinical Trial site 15634
state: Tianjin
city: Xian
country: China
facility: Chiesi Clinical Trial site 15626
state: Xian
city: Beijing
country: China
facility: Chiesi Clinical Trial site 15672
city: Beijing
country: China
facility: Chiesi clinical Trial site 15636
city: Chongqing
country: China
facility: Chiesi Clinical Trial site 15638
city: Guizhou
country: China
facility: Chiesi Clinical Trial site 15670
city: Hebei
country: China
facility: Chiesi clinical Trial Site 15611
city: Jilin
country: China
facility: Chiesi Clinical trial site 15660
city: Shanghai
country: China
facility: Chiesi Clinical Trial site 15628
city: Shanghai
country: China
facility: Chiesi clinical trial site 15637
city: Shenzhen
country: China
facility: Chiesi Clinical Trial site 15666
city: Sichuan
country: China
facility: Chiesi clinical Trial site 15633
city: Ürümqi
country: China
facility: Chiesi Clinical Trial site 15669
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jinping MD Zheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng J, Zhang J, Fu X, Lin C, Zhang X, Mei X, Corradi M, Cappellini G, Calabro E, Zhu C, Topole E. Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. J Asthma. 2024 Apr;61(4):360-367. doi: 10.1080/02770903.2023.2272816. Epub 2023 Nov 1.