Back to resultsFoster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma. (FORTUNE)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Foster 100/6mg NEXThaler
Foster 100/6mg pMDI
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Peek Expiratory Flow (PEF) Lung function tests
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
Sites / Locations
- Chiesi Clinical Trial site 15641
- Chiesi Clinical Trial site 15682
- Chiesi Clinical Trial site 15663
- Chiesi Clinical Trial site 15662
- Chiesi Clinical Trial site 15671
- Chiesi clinical Trial Site 15610
- Chiesi clinical Trial site 15656
- Chiesi Clinical Trial site 15668
- Chiesi Clinical Trial site 15677
- Chiesi Clinical Trial site 15683
- Chiesi Clinical Trial site 15608
- Chiesi Clinical Trial site 15607
- Chiesi Clinical Trial site 15610
- Chiesi Clinical Trial site 15668
- Chiesi Clinical Trial site 15673
- Chiesi Clinical Trial site 15678
- Chiesi Clinical Trial site 15681
- Chiesi Clinical Trial site 15679
- Chiesi Clinical Trial site 15614
- Chiesi Clinical Trial site 15661
- Chiesi Clinical Trial site 15675
- Chiesi Clinical Trial site 15643
- Chiesi Clinical Trial site 15674
- Chiesi Clinical Trial site 15676
- Chiesi clinical Trial site 15621
- Chiesi clinical Trial site 15619
- Chiesi Clinical Trial site 15650
- Chiesi clinical Trial site 15659
- Chiesi Clinical Trial site 15625
- Chiesi Clinical Trial site 15630
- Chiesi Clinical Trial site 15664
- Chiesi Clinical Trial site 15654
- Chiesi Clinical Trial site 15630
- Chiesi Clinical Trial site 15631
- Chiesi Clinical Trial site 15665
- Chiesi Clinical Trial site 15611
- Chiesi Clinical Trial site 15633
- Chiesi Clinical Trial site 15680
- Chiesi Clinical Trial site 15642
- Chiesi Clinical Trial site 15634
- Chiesi Clinical Trial site 15626
- Chiesi Clinical Trial site 15672
- Chiesi clinical Trial site 15636
- Chiesi Clinical Trial site 15638
- Chiesi Clinical Trial site 15670
- Chiesi clinical Trial Site 15611
- Chiesi Clinical trial site 15660
- Chiesi Clinical Trial site 15628
- Chiesi clinical trial site 15637
- Chiesi Clinical Trial site 15666
- Chiesi clinical Trial site 15633
- Chiesi Clinical Trial site 15669
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Foster 100/6mg NEXThaler
Foster 100/6mg pMDI
Arm Description
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler (NEXThaler)
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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
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.
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)
Full Information
NCT ID
NCT03453112
First Posted
February 12, 2018
Last Updated
March 20, 2023
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT03453112
Brief Title
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Peek Expiratory Flow (PEF) Lung function tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
494 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foster 100/6mg NEXThaler
Arm Type
Experimental
Arm Description
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler (NEXThaler)
Arm Title
Foster 100/6mg pMDI
Arm Type
Active Comparator
Arm Description
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.
Intervention Type
Drug
Intervention Name(s)
Foster 100/6mg NEXThaler
Intervention Description
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Foster 100/6mg pMDI
Intervention Description
Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant
Primary Outcome Measure Information:
Title
Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function
Description
Change from Baseline to the entire treatment period in average pre-dose morning Peek Expiratory flow (PEF)
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
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
Description
Changes in average pre-dose morning Peek Expiratory flow (PEF)
Time Frame
Baseline to week 12
Title
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
Description
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
Time Frame
Baseline to week 12
Title
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
Description
Changes from Baseline in pre-dose morning Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at each clinic visit.
Time Frame
Baseline to Week 12
Title
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
Description
Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ)
Time Frame
Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinping MD Zheng
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi Clinical Trial site 15641
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Chiesi Clinical Trial site 15682
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chiesi Clinical Trial site 15663
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Facility Name
Chiesi Clinical Trial site 15662
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
Chiesi Clinical Trial site 15671
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
5100150
Country
China
Facility Name
Chiesi clinical Trial Site 15610
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Chiesi clinical Trial site 15656
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Chiesi Clinical Trial site 15668
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Chiesi Clinical Trial site 15677
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Facility Name
Chiesi Clinical Trial site 15683
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518052
Country
China
Facility Name
Chiesi Clinical Trial site 15608
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Chiesi Clinical Trial site 15607
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Name
Chiesi Clinical Trial site 15610
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
511400
Country
China
Facility Name
Chiesi Clinical Trial site 15668
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
511400
Country
China
Facility Name
Chiesi Clinical Trial site 15673
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Chiesi Clinical Trial site 15678
City
Qiqihar
State/Province
Heilongjiang
ZIP/Postal Code
161002
Country
China
Facility Name
Chiesi Clinical Trial site 15681
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Facility Name
Chiesi Clinical Trial site 15679
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Chiesi Clinical Trial site 15614
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Chiesi Clinical Trial site 15661
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Chiesi Clinical Trial site 15675
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421000
Country
China
Facility Name
Chiesi Clinical Trial site 15643
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213164
Country
China
Facility Name
Chiesi Clinical Trial site 15674
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
Chiesi Clinical Trial site 15676
City
Jilin
State/Province
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
Chiesi clinical Trial site 15621
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Chiesi clinical Trial site 15619
City
Nanchang
State/Province
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Chiesi Clinical Trial site 15650
City
Hohhot
State/Province
Neimenggu
ZIP/Postal Code
010017
Country
China
Facility Name
Chiesi clinical Trial site 15659
City
Hohhot
State/Province
Neimenggu
Country
China
Facility Name
Chiesi Clinical Trial site 15625
City
Taiyuan
State/Province
Shan XI Province
ZIP/Postal Code
030001
Country
China
Facility Name
Chiesi Clinical Trial site 15630
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Chiesi Clinical Trial site 15664
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Chiesi Clinical Trial site 15654
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Chiesi Clinical Trial site 15630
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chiesi Clinical Trial site 15631
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chiesi Clinical Trial site 15665
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chiesi Clinical Trial site 15611
City
Shijiazhuang
State/Province
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Chiesi Clinical Trial site 15633
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chiesi Clinical Trial site 15680
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
408499
Country
China
Facility Name
Chiesi Clinical Trial site 15642
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Chiesi Clinical Trial site 15634
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China
Facility Name
Chiesi Clinical Trial site 15626
City
Xian
State/Province
Xian
ZIP/Postal Code
710061
Country
China
Facility Name
Chiesi Clinical Trial site 15672
City
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Chiesi clinical Trial site 15636
City
Beijing
Country
China
Facility Name
Chiesi Clinical Trial site 15638
City
Chongqing
Country
China
Facility Name
Chiesi Clinical Trial site 15670
City
Guizhou
Country
China
Facility Name
Chiesi clinical Trial Site 15611
City
Hebei
Country
China
Facility Name
Chiesi Clinical trial site 15660
City
Jilin
Country
China
Facility Name
Chiesi Clinical Trial site 15628
City
Shanghai
Country
China
Facility Name
Chiesi clinical trial site 15637
City
Shanghai
Country
China
Facility Name
Chiesi Clinical Trial site 15666
City
Shenzhen
Country
China
Facility Name
Chiesi clinical Trial site 15633
City
Sichuan
Country
China
Facility Name
Chiesi Clinical Trial site 15669
City
Ürümqi
ZIP/Postal Code
830054
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.chiesi.com/en/chiesi-clinical-study-register/
Description
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.
Learn more about this trial
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
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