TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

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

1153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-17

Study Completion Date

2018-05-17

Brief Summary

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The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

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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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CHF 5993 100/6/12.5 µg

Treatment A:

CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB

Group Type EXPERIMENTAL

CHF 5993 100/6/12.5 µg

Intervention Type DRUG

CHF 1535 100/6 µg

Treatment B :

CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

Group Type ACTIVE_COMPARATOR

CHF 1535 100/6 µg

Intervention Type DRUG

Interventions

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CHF 5993 100/6/12.5 µg

Intervention Type DRUG

CHF 1535 100/6 µg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of asthma ≥ 1 year and diagnosed before 40 years old
* Uncontrolled asthma with double therapy only on medium doses of Inhaled CorticoSteroid (ICS) in combination with Long-acting beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
* Pre-bronchodilator FEV1 \<80% of the predicted normal value
* Positive reversibility test
* At least 1 documented asthma exacerbation in the previous year

Exclusion Criteria

* Pregnant or lactating women
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
* Current or ex-smokers (\>= 10 packs year)
* Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No