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Completed

NCT Number: NCT03453112

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chiesi Clinical Trial site 15641, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Foster 100/6mg pMDI

Drug

Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant

Primary outcomes

  1. Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function

    Time frame: Baseline to week 12

    Change from Baseline to the entire treatment period in average pre-dose morning Peek Expiratory flow (PEF)

Secondary outcomes

  1. 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

    Time frame: Baseline to week 12

    Changes in average pre-dose morning Peek Expiratory flow (PEF)

  2. 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

    Time frame: Baseline to week 12

    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

  3. 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

    Time frame: Baseline to Week 12

    Changes from Baseline in pre-dose morning Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at each clinic visit.

  4. 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

    Time frame: Baseline to week 12

    Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ)

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: FORTUNE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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