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

November 22, 2023 updated by: Chiesi Farmaceutici S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100144
        • Chiesi Clinical Trial site 15672
      • Beijing, China
        • Chiesi clinical Trial site 15636
      • Chongqing, China
        • Chiesi Clinical Trial site 15638
      • Guizhou, China
        • Chiesi Clinical Trial site 15670
      • Hebei, China
        • Chiesi clinical Trial Site 15611
      • Jilin, China
        • Chiesi Clinical trial site 15660
      • Shanghai, China
        • Chiesi Clinical Trial site 15628
      • Shanghai, China
        • Chiesi clinical trial site 15637
      • Shenzhen, China
        • Chiesi Clinical Trial site 15666
      • Sichuan, China
        • Chiesi clinical Trial site 15633
      • Ürümqi, China, 830054
        • Chiesi Clinical Trial site 15669
    • Anhui
      • Hefei, Anhui, China
        • Chiesi Clinical Trial site 15641
    • Beijing
      • Beijing, Beijing, China, 100000
        • Chiesi Clinical Trial site 15682
      • Beijing, Beijing, China, 101100
        • Chiesi Clinical Trial site 15663
    • Guangdong
      • Foshan, Guangdong, China
        • Chiesi Clinical Trial site 15662
      • Guangzhou, Guangdong, China, 5100150
        • Chiesi Clinical Trial site 15671
      • Guangzhou, Guangdong, China, 510120
        • Chiesi Clinical Trial site 15610
      • Guangzhou, Guangdong, China
        • Chiesi clinical Trial site 15656
      • Guangzhou, Guangdong, China
        • Chiesi Clinical Trial site 15668
      • Huizhou, Guangdong, China, 516001
        • Chiesi Clinical Trial site 15677
      • Shenzhen, Guangdong, China, 518052
        • Chiesi Clinical Trial site 15683
      • Shenzhen, Guangdong, China
        • Chiesi Clinical Trial site 15608
      • Zhanjiang, Guangdong, China, 524001
        • Chiesi Clinical Trial site 15607
    • Guangzhou
      • Guangzhou, Guangzhou, China, 511400
        • Chiesi Clinical Trial site 15610
      • Guangzhou, Guangzhou, China, 511400
        • Chiesi Clinical Trial site 15668
    • Hainan
      • Haikou, Hainan, China, 570208
        • Chiesi Clinical Trial site 15673
    • Heilongjiang
      • Qiqihar, Heilongjiang, China, 161002
        • Chiesi Clinical Trial site 15678
    • Henan
      • Xinxiang, Henan, China, 453000
        • Chiesi Clinical Trial site 15681
      • Zhengzhou, Henan, China, 450003
        • Chiesi Clinical Trial site 15679
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Chiesi Clinical Trial site 15614
      • Wuhan, Hubei, China
        • Chiesi Clinical Trial site 15661
    • Hunan
      • Hengyang, Hunan, China, 421000
        • Chiesi Clinical Trial site 15675
    • Jiangsu
      • Changzhou, Jiangsu, China, 213164
        • Chiesi Clinical Trial site 15643
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Chiesi Clinical Trial site 15674
    • Jilin
      • Jilin, Jilin, China, 132011
        • Chiesi Clinical Trial site 15676
    • Liaoning
      • Shenyang, Liaoning, China
        • Chiesi clinical Trial site 15621
    • Nanchang
      • Nanchang, Nanchang, China, 330006
        • Chiesi clinical Trial site 15619
    • Neimenggu
      • Hohhot, Neimenggu, China, 010017
        • Chiesi Clinical Trial site 15650
      • Hohhot, Neimenggu, China
        • Chiesi clinical Trial site 15659
    • Shan XI Province
      • Taiyuan, Shan XI Province, China, 030001
        • Chiesi Clinical Trial site 15625
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai, China, 200050
        • Chiesi Clinical Trial site 15664
      • Shanghai, Shanghai, China, 201100
        • Chiesi Clinical Trial site 15654
      • Shanghai, Shanghai, China
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai, China
        • Chiesi Clinical Trial site 15631
      • Shanghai, Shanghai, China
        • Chiesi Clinical Trial site 15665
    • Shijiazhuang
      • Shijiazhuang, Shijiazhuang, China, 050000
        • Chiesi clinical Trial Site 15611
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Chiesi clinical Trial site 15633
      • Chongqing, Sichuan, China, 408499
        • Chiesi Clinical Trial site 15680
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Chiesi Clinical Trial site 15642
      • Tianjin, Tianjin, China, 300350
        • Chiesi Clinical Trial site 15634
    • Xian
      • Xian, Xian, China, 710061
        • Chiesi Clinical Trial site 15626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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
Active Comparator: Foster 100/6mg pMDI
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.
Drug: Foster 100/6mg pMDI
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to week 12
Changes in average pre-dose morning Peek Expiratory flow (PEF)
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
Time Frame: Baseline to week 12
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
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
Time Frame: Baseline to Week 12
Changes from Baseline in pre-dose morning Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at each clinic visit.
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
Time Frame: Baseline to week 12
Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ)
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Jinping MD Zheng, The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2017

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-01535BA0-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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