Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinping MD Zheng | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi Clinical Trial site 15641 | Hefei | Anhui | China | |||
| Chiesi Clinical Trial site 15682 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37878325 | Result | 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. |
| Label | URL |
|---|---|
| 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. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 20, 2026 | |
| Reset | Feb 4, 2026 | |
| Release | Feb 27, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Foster 100/6mg pMDI | Drug | Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant |
|
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 | 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 | Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ) | Baseline to week 12 |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Chiesi Clinical Trial site 15663 | Beijing | Beijing Municipality | 101100 | China |
| Chiesi Clinical Trial site 15662 | Foshan | Guangdong | China |
| Chiesi Clinical Trial site 15671 | Guangzhou | Guangdong | 5100150 | China |
| Chiesi clinical Trial Site 15610 | Guangzhou | Guangdong | 510120 | China |
| Chiesi clinical Trial site 15656 | Guangzhou | Guangdong | China |
| Chiesi Clinical Trial site 15668 | Guangzhou | Guangdong | China |
| Chiesi Clinical Trial site 15677 | Huizhou | Guangdong | 516001 | China |
| Chiesi Clinical Trial site 15683 | Shenzhen | Guangdong | 518052 | China |
| Chiesi Clinical Trial site 15608 | Shenzhen | Guangdong | China |
| Chiesi Clinical Trial site 15607 | Zhanjiang | Guangdong | 524001 | China |
| Chiesi Clinical Trial site 15610 | Guangzhou | Guangzhou | 511400 | China |
| Chiesi Clinical Trial site 15668 | Guangzhou | Guangzhou | 511400 | China |
| Chiesi Clinical Trial site 15673 | Haikou | Hainan | 570208 | China |
| Chiesi Clinical Trial site 15678 | Qiqihar | Heilongjiang | 161002 | China |
| Chiesi Clinical Trial site 15681 | Xinxiang | Henan | 453000 | China |
| Chiesi Clinical Trial site 15679 | Zhengzhou | Henan | 450003 | China |
| Chiesi Clinical Trial site 15614 | Wuhan | Hubei | 430030 | China |
| Chiesi Clinical Trial site 15661 | Wuhan | Hubei | China |
| Chiesi Clinical Trial site 15675 | Hengyang | Hunan | 421000 | China |
| Chiesi Clinical Trial site 15643 | Changzhou | Jiangsu | 213164 | China |
| Chiesi Clinical Trial site 15674 | Pingxiang | Jiangxi | 337055 | China |
| Chiesi Clinical Trial site 15676 | Jilin City | Jilin | 132011 | China |
| Chiesi clinical Trial site 15621 | Shenyang | Liaoning | China |
| Chiesi clinical Trial site 15619 | Nanchang | Nanchang | 330006 | China |
| Chiesi Clinical Trial site 15650 | Hohhot | Neimenggu | 010017 | China |
| Chiesi clinical Trial site 15659 | Hohhot | Neimenggu | China |
| Chiesi Clinical Trial site 15630 | Shanghai | Shanghai Municipality | 200025 | China |
| Chiesi Clinical Trial site 15664 | Shanghai | Shanghai Municipality | 200050 | China |
| Chiesi Clinical Trial site 15654 | Shanghai | Shanghai Municipality | 201100 | China |
| Chiesi Clinical Trial site 15630 | Shanghai | Shanghai Municipality | China |
| Chiesi Clinical Trial site 15631 | Shanghai | Shanghai Municipality | China |
| Chiesi Clinical Trial site 15665 | Shanghai | Shanghai Municipality | China |
| Chiesi Clinical Trial site 15625 | Taiyuan | Shanxi | 030001 | China |
| Chiesi Clinical Trial site 15611 | Shijiazhuang | Shijiazhuang | 050000 | China |
| Chiesi Clinical Trial site 15633 | Chengdu | Sichuan | 610041 | China |
| Chiesi Clinical Trial site 15680 | Chongqing | Sichuan | 408499 | China |
| Chiesi Clinical Trial site 15642 | Tianjin | Tianjin Municipality | 300052 | China |
| Chiesi Clinical Trial site 15634 | Tianjin | Tianjin Municipality | 300350 | China |
| Chiesi Clinical Trial site 15626 | Xi'an | Xian | 710061 | China |
| Chiesi Clinical Trial site 15672 | Beijing | 100144 | China |
| Chiesi clinical Trial site 15636 | Beijing | China |
| Chiesi Clinical Trial site 15638 | Chongqing | China |
| Chiesi Clinical Trial site 15670 | Guizhou | China |
| Chiesi clinical Trial Site 15611 | Hebei | China |
| Chiesi Clinical trial site 15660 | Jilin City | China |
| Chiesi Clinical Trial site 15628 | Shanghai | China |
| Chiesi clinical trial site 15637 | Shanghai | China |
| Chiesi Clinical Trial site 15666 | Shenzhen | China |
| Chiesi clinical Trial site 15633 | Sichuan | China |
| Chiesi Clinical Trial site 15669 | Ürümqi | 830054 | China |
| Reset | Mar 18, 2026 |
| Release | Apr 20, 2026 |
| Reset | May 11, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2026 | Feb 4, 2026 | |||
| Feb 27, 2026 | Mar 18, 2026 | |||
| Apr 20, 2026 | May 11, 2026 | |||
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005581 | Foster Home Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided