Triple in Asthma Dose Finding

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: CHF 5259 plus Foster 100/6 µg; Drug: Foster 100/6 µg

• Registration Number: NCT02127866
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 5259 25 µg plus Foster 100/6 µg	CHF 5259 plus Foster 100/6 µg	-
CHF 5259 50 µg plus Foster 100/6 µg	CHF 5259 plus Foster 100/6 µg	-
CHF 5259 100 µg plus Foster 100/6 µg	CHF 5259 plus Foster 100/6 µg	-
Foster 100/6 µg	Foster 100/6 µg	-

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-12h normalised by time on Day 42	Day 42

Secondary Outcome Measures

Name	Time	Method
Peak FEV1 on Day 42	Day 42
Adverse Events and Adverse Drug Reactions	Up at Week 24 (study end)

Trial Locations

Locations (44)

Chiesi Clinical Trial Site 0105; 🇧🇬 Dupnitza, Bulgaria

Chiesi Clinical Trial Site 0101; 🇧🇬 Ruse, Bulgaria

Chiesi Clinical Trial Site 0106; 🇧🇬 Sevlievo, Bulgaria

Chiesi Clinical Trial Site 0107; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0108; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0102; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0110; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0109; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0103; 🇧🇬 Stara Zagora, Bulgaria

Chiesi Clinical Trial Site 0104; 🇧🇬 Troyan, Bulgaria

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