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Foster 100/6 mg NEXThaler Ver...

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

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2021-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Foster 100/6mg NEXThaler

Intervention Type DRUG

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler

Foster 100/6mg pMDI

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant.

Group Type ACTIVE_COMPARATOR

Foster 100/6mg pMDI

Intervention Type DRUG

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA\_134a propellant

Interventions

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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

Intervention Type DRUG

Foster 100/6mg pMDI

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA\_134a propellant

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinping MD Zheng

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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Chiesi Clinical Trial site 15641

Hefei, Anhui, China

Site Status

Chiesi Clinical Trial site 15682

Beijing, Beijing Municipality, China

Site Status

Chiesi Clinical Trial site 15663

Beijing, Beijing Municipality, China

Site Status

Chiesi Clinical Trial site 15662

Foshan, Guangdong, China

Site Status

Chiesi Clinical Trial site 15671

Guangzhou, Guangdong, China

Site Status

Chiesi clinical Trial Site 15610

Guangzhou, Guangdong, China

Site Status

Chiesi clinical Trial site 15656

Guangzhou, Guangdong, China

Site Status

Chiesi Clinical Trial site 15668

Guangzhou, Guangdong, China

Site Status

Chiesi Clinical Trial site 15677

Huizhou, Guangdong, China

Site Status

Chiesi Clinical Trial site 15683

Shenzhen, Guangdong, China

Site Status

Chiesi Clinical Trial site 15608

Shenzhen, Guangdong, China

Site Status

Chiesi Clinical Trial site 15607

Zhanjiang, Guangdong, China

Site Status

Chiesi Clinical Trial site 15610

Guangzhou, Guangzhou, China

Site Status

Chiesi Clinical Trial site 15668

Guangzhou, Guangzhou, China

Site Status

Chiesi Clinical Trial site 15673

Haikou, Hainan, China

Site Status

Chiesi Clinical Trial site 15678

Qiqihar, Heilongjiang, China

Site Status

Chiesi Clinical Trial site 15681

Xinxiang, Henan, China

Site Status

Chiesi Clinical Trial site 15679

Zhengzhou, Henan, China

Site Status

Chiesi Clinical Trial site 15614

Wuhan, Hubei, China

Site Status

Chiesi Clinical Trial site 15661

Wuhan, Hubei, China

Site Status

Chiesi Clinical Trial site 15675

Hengyang, Hunan, China

Site Status

Chiesi Clinical Trial site 15643

Changzhou, Jiangsu, China

Site Status

Chiesi Clinical Trial site 15674

Pingxiang, Jiangxi, China

Site Status

Chiesi Clinical Trial site 15676

Jilin, Jilin, China

Site Status

Chiesi clinical Trial site 15621

Shenyang, Liaoning, China

Site Status

Chiesi clinical Trial site 15619

Nanchang, Nanchang, China

Site Status

Chiesi Clinical Trial site 15650

Hohhot, Neimenggu, China

Site Status