Triple in Asthma Dose Finding (Triskel)

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Foster 100/6 µg; Drug: CHF 5259 plus Foster 100/6 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02127866

CCD-1206-PR-0088

2013-003043-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged >=18 years
• Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5
• Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value

Exclusion criteria

• Pregnant or lactating women
• Diagnosis of COPD
• Patients treated for asthma exacerbations 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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211 participants in 4 patient groups

CHF 5259 25 µg plus Foster 100/6 µg

Experimental group

Treatment:

Drug: CHF 5259 plus Foster 100/6 µg

CHF 5259 50 µg plus Foster 100/6 µg

Experimental group

Treatment:

Drug: CHF 5259 plus Foster 100/6 µg

CHF 5259 100 µg plus Foster 100/6 µg

Experimental group

Treatment:

Drug: CHF 5259 plus Foster 100/6 µg

Foster 100/6 µg

Active Comparator group

Treatment:

Drug: Foster 100/6 µg