Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: CHF 5259 12.5 µg; Drug: CHF 5259 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02296411

CCD-05993AB1-02

2014-001442-16 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.

Enrollment: 98 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of asthma ≥ 5 years and diagnosed before 40 years old
• Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5
• Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value
• Positive reversibility test

Exclusion criteria

• Pregnant or lactating women
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Patients treated for asthma exacerbation in the 4 weeks prior to study entry
• Patients who are in therapy for gastroesophageal reflux disease
• Patients who have a clinically significant cardiovascular condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

CHF 5259 12.5 µg

Experimental group

Description:

CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)

Treatment:

Drug: CHF 5259 12.5 µg

CHF 5259 placebo

Placebo Comparator group

Description:

CHF 5259 placebo: 2 inhalations bid

Treatment:

Drug: CHF 5259 placebo