Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Study Identifier:
CCD-01535BA0-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Clinical Study Report
Available Languages: English
Plain Language Summary
Available Languages: Chinese (China), English
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: Foster 100/6mg NEXThaler
- Drug: Foster 100/6mg pMDI
Date
Oct 2017 - Dec 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No
Protocol 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.
Study Locations
Location
Status
Location
Chiesi Clinical Trial site 15641
Hefei, Anhui, China
Status
N/A
Location
Chiesi Clinical Trial site 15682
Beijing, Beijing Municipality, China, 100000
Status
N/A
Location
Chiesi Clinical Trial site 15663
Beijing, Beijing Municipality, China, 101100
Status
N/A
Location
Chiesi Clinical Trial site 15662
Foshan, Guangdong, China
Status
N/A
Location
Chiesi Clinical Trial site 15671
Guangzhou, Guangdong, China, 5100150
Status
N/A
Location
Chiesi clinical Trial Site 15610
Guangzhou, Guangdong, China, 510120
Status
N/A
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