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

NCT03453112 | Completed Phase 3

• 1 other identifier: CCD-01535BA0-01
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 52

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.

Conditions

Asthma

Keywords

Peek Expiratory Flow (PEF) Lung function tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Foster 100/6mg NEXThaler

EXPERIMENTAL

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

Drug: Foster 100/6mg NEXThaler

Foster 100/6mg pMDI

ACTIVE COMPARATOR

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

Drug: Foster 100/6mg pMDI

Interventions

Foster 100/6mg NEXThaler DRUG

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

Foster 100/6mg NEXThaler

Foster 100/6mg pMDI DRUG

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA\_134a propellant

Foster 100/6mg pMDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (52)

Chiesi Clinical Trial site 15641

Hefei, Anhui, China

Location

Chiesi Clinical Trial site 15682

Beijing, Beijing Municipality, 100000, China

Location

Chiesi Clinical Trial site 15663

Beijing, Beijing Municipality, 101100, China

Location

Chiesi Clinical Trial site 15662

Foshan, Guangdong, China

Location

Chiesi Clinical Trial site 15671

Guangzhou, Guangdong, 5100150, China

Location

Chiesi clinical Trial Site 15610

Guangzhou, Guangdong, 510120, China

Location

Chiesi clinical Trial site 15656

Guangzhou, Guangdong, China

Location

Chiesi Clinical Trial site 15668

Guangzhou, Guangdong, China

Location

Chiesi Clinical Trial site 15677

Huizhou, Guangdong, 516001, China

Location

Chiesi Clinical Trial site 15683

Shenzhen, Guangdong, 518052, China

Location

Chiesi Clinical Trial site 15608

Shenzhen, Guangdong, China

Location

Chiesi Clinical Trial site 15607

Zhanjiang, Guangdong, 524001, China

Location

Chiesi Clinical Trial site 15610

Guangzhou, Guangzhou, 511400, China

Location

Chiesi Clinical Trial site 15668

Guangzhou, Guangzhou, 511400, China

Location

Chiesi Clinical Trial site 15673

Haikou, Hainan, 570208, China

Location

Chiesi Clinical Trial site 15678

Qiqihar, Heilongjiang, 161002, China

Location

Chiesi Clinical Trial site 15681

Xinxiang, Henan, 453000, China

Location

Chiesi Clinical Trial site 15679

Zhengzhou, Henan, 450003, China

Location

Chiesi Clinical Trial site 15614

Wuhan, Hubei, 430030, China

Location

Chiesi Clinical Trial site 15661

Wuhan, Hubei, China

Location

Chiesi Clinical Trial site 15675

Hengyang, Hunan, 421000, China

Location

Chiesi Clinical Trial site 15643

Changzhou, Jiangsu, 213164, China

Location

Chiesi Clinical Trial site 15674

Pingxiang, Jiangxi, 337055, China

Location

Chiesi Clinical Trial site 15676

Jilin, Jilin, 132011, China

Location

Chiesi clinical Trial site 15621

Shenyang, Liaoning, China

Location

Chiesi clinical Trial site 15619

Nanchang, Nanchang, 330006, China

Location

Chiesi Clinical Trial site 15650

Hohhot, Neimenggu, 010017, China

Location

Chiesi clinical Trial site 15659

Hohhot, Neimenggu, China

Location

Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, 200025, China

Location

Chiesi Clinical Trial site 15664

Shanghai, Shanghai Municipality, 200050, China

Location

Chiesi Clinical Trial site 15654

Shanghai, Shanghai Municipality, 201100, China

Location

Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15631

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15665

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15625

Taiyuan, Shanxi, 030001, China

Location

Chiesi Clinical Trial site 15611

Shijiazhuang, Shijiazhuang, 050000, China

Location

Chiesi Clinical Trial site 15633

Chengdu, Sichuan, 610041, China

Location

Chiesi Clinical Trial site 15680

Chongqing, Sichuan, 408499, China

Location

Chiesi Clinical Trial site 15642

Tianjin, Tianjin Municipality, 300052, China

Location

Chiesi Clinical Trial site 15634

Tianjin, Tianjin Municipality, 300350, China

Location

Chiesi Clinical Trial site 15626

Xi'an, Xian, 710061, China

Location

Chiesi Clinical Trial site 15672

Beijing, 100144, China

Location

Chiesi clinical Trial site 15636

Beijing, China

Location

Chiesi Clinical Trial site 15638

Chongqing, China

Location

Chiesi Clinical Trial site 15670

Guizhou, China

Location

Chiesi clinical Trial Site 15611

Hebei, China

Location

Chiesi Clinical trial site 15660

Jilin, China

Location

Chiesi Clinical Trial site 15628

Shanghai, China

Location

Chiesi clinical trial site 15637

Shanghai, China

Location

Chiesi Clinical Trial site 15666

Shenzhen, China

Location

Chiesi clinical Trial site 15633

Sichuan, China

Location

Chiesi Clinical Trial site 15669

Ürümqi, 830054, China

Location

Related 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 asthma: the FORTUNE study. J Asthma. 2024 Apr;61(4):360-367. doi: 10.1080/02770903.2023.2272816. Epub 2023 Nov 1.

  PMID: 37878325 RESULT

Related 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.

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jinping MD Zheng

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 5, 2018
• Study Start: October 9, 2017
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (52)