Status:
COMPLETED
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT03453112
Start Date
October 9 2017
End Date
December 28 2021
Last Update
November 28 2023
Active Locations (52)
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1
Chiesi Clinical Trial site 15641
Hefei, Anhui, China
2
Chiesi Clinical Trial site 15682
Beijing, Beijing Municipality, China, 100000
3
Chiesi Clinical Trial site 15663
Beijing, Beijing Municipality, China, 101100
4
Chiesi Clinical Trial site 15662
Foshan, Guangdong, China