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

Asthma Clinical Trial

— FORTUNE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453112
• Other study ID #: CCD-01535BA0-01
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2017
• Est. completion date: December 28, 2021

Study information

• Verified date: November 2023
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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
• Foster 100/6mg pMDI
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant

Locations

Country	Name	City	State
China	Chiesi clinical Trial site 15636	Beijing
China	Chiesi Clinical Trial site 15663	Beijing	Beijing
China	Chiesi Clinical Trial site 15672	Beijing
China	Chiesi Clinical Trial site 15682	Beijing	Beijing
China	Chiesi Clinical Trial site 15643	Changzhou	Jiangsu
China	Chiesi Clinical Trial site 15633	Chengdu	Sichuan
China	Chiesi Clinical Trial site 15638	Chongqing
China	Chiesi Clinical Trial site 15680	Chongqing	Sichuan
China	Chiesi Clinical Trial site 15662	Foshan	Guangdong
China	Chiesi clinical Trial Site 15610	Guangzhou	Guangdong
China	Chiesi Clinical Trial site 15610	Guangzhou	Guangzhou
China	Chiesi clinical Trial site 15656	Guangzhou	Guangdong
China	Chiesi Clinical Trial site 15668	Guangzhou	Guangdong
China	Chiesi Clinical Trial site 15668	Guangzhou	Guangzhou
China	Chiesi Clinical Trial site 15671	Guangzhou	Guangdong
China	Chiesi Clinical Trial site 15670	Guizhou
China	Chiesi Clinical Trial site 15673	Haikou	Hainan
China	Chiesi clinical Trial Site 15611	Hebei
China	Chiesi Clinical Trial site 15641	Hefei	Anhui
China	Chiesi Clinical Trial site 15675	Hengyang	Hunan
China	Chiesi Clinical Trial site 15650	Hohhot	Neimenggu
China	Chiesi clinical Trial site 15659	Hohhot	Neimenggu
China	Chiesi Clinical Trial site 15677	Huizhou	Guangdong
China	Chiesi Clinical trial site 15660	Jilin
China	Chiesi Clinical Trial site 15676	Jilin	Jilin
China	Chiesi clinical Trial site 15619	Nanchang	Nanchang
China	Chiesi Clinical Trial site 15674	Pingxiang	Jiangxi
China	Chiesi Clinical Trial site 15678	Qiqihar	Heilongjiang
China	Chiesi Clinical Trial site 15628	Shanghai
China	Chiesi Clinical Trial site 15630	Shanghai	Shanghai
China	Chiesi Clinical Trial site 15630	Shanghai	Shanghai
China	Chiesi Clinical Trial site 15631	Shanghai	Shanghai
China	Chiesi clinical trial site 15637	Shanghai
China	Chiesi Clinical Trial site 15654	Shanghai	Shanghai
China	Chiesi Clinical Trial site 15664	Shanghai	Shanghai
China	Chiesi Clinical Trial site 15665	Shanghai	Shanghai
China	Chiesi clinical Trial site 15621	Shenyang	Liaoning
China	Chiesi Clinical Trial site 15608	Shenzhen	Guangdong
China	Chiesi Clinical Trial site 15666	Shenzhen
China	Chiesi Clinical Trial site 15683	Shenzhen	Guangdong
China	Chiesi Clinical Trial site 15611	Shijiazhuang	Shijiazhuang
China	Chiesi clinical Trial site 15633	Sichuan
China	Chiesi Clinical Trial site 15625	Taiyuan	Shan XI Province
China	Chiesi Clinical Trial site 15634	Tianjin	Tianjin
China	Chiesi Clinical Trial site 15642	Tianjin	Tianjin
China	Chiesi Clinical Trial site 15669	Ürümqi
China	Chiesi Clinical Trial site 15614	Wuhan	Hubei
China	Chiesi Clinical Trial site 15661	Wuhan	Hubei
China	Chiesi Clinical Trial site 15626	Xian	Xian
China	Chiesi Clinical Trial site 15681	Xinxiang	Henan
China	Chiesi Clinical Trial site 15607	Zhanjiang	Guangdong
China	Chiesi Clinical Trial site 15679	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

China, 

References & Publications (1)

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 as — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function	Change from Baseline to the entire treatment period in average pre-dose morning Peek Expiratory flow (PEF)	Baseline to week 12
Secondary	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	Changes in average pre-dose morning Peek Expiratory flow (PEF)	Baseline to week 12
Secondary	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	Changes in average pre-dose evening PEF Daily PEF variability Average use fo rescue medication (number of puffs/day) Percentage of rescue-use free days Average total morning asthma symptom scores Average total evening asthma symptom scores Percentage of asthma symptoms-free days Percentage of asthma control days	Baseline to week 12
Secondary	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	Changes from Baseline in pre-dose morning Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at each clinic visit.	Baseline to Week 12
Secondary	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	Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ)	Baseline to week 12

External Links

•   Lay Summary of clinical trial results is available both in English and Chinese on the Chiesi Group web-site, along with a copy of the CSR synopsis.