Efficacy of LAMA Added to ICS in Treatment of Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: CHF 5259 12.5 µg; Drug: CHF 5259 placebo

• Registration Number: NCT02296411
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-20
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 5259 12.5 µg	CHF 5259 12.5 µg	CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)
CHF 5259 placebo	CHF 5259 placebo	CHF 5259 placebo: 2 inhalations bid

Primary Outcome Measures

Name	Time	Method
FEV1 (Forced Expiratory Volume in the first second) AUC0-12h (Area Under the Curve for 0-12 hours) normalised by time on Day 42	Day 42

Secondary Outcome Measures

Name	Time	Method
Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42	Day 42

Trial Locations

Locations (28)

Chiesi Clinical Trial Site 0202; 🇩🇪 Leipzig, Germany

Chiesi Clinical Trial Site 0206; 🇩🇪 Magdeburg, Germany

Chiesi Clinical Trial Site 0404; 🇳🇱 Assen, Netherlands

Chiesi Clinical Trial Site 0405; 🇳🇱 Helmond, Netherlands

Chiesi Clinical Trial Site 0102; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0507; 🇵🇱 Krakow, Poland

Chiesi Clinical Trial Site 0505; 🇵🇱 Wroclaw, Poland

Chiesi Clinical Trial Site 0203; 🇩🇪 Leipzig, Germany

Chiesi Clinical Trial Site 0503; 🇵🇱 Elblag, Poland

Chiesi Clinical Trial Site 0301; 🇮🇹 Pisa, Italy

Chiesi Clinical Trial Site 0304; 🇮🇹 Pisa, Italy

Chiesi Clinical Trial Site 0502; 🇵🇱 Bialystok, Poland

Chiesi Clinical Trial Site 0504; 🇵🇱 Krakow, Poland

Chiesi Clinical Trial Site 0103; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0109; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0510; 🇵🇱 Lodz, Poland

Chiesi Clinical Trial Site 0107; 🇧🇬 Ruse, Bulgaria

Chiesi Clinical Trial Site 0106; 🇧🇬 Sevlievo, Bulgaria

Chiesi Clinical Trial Site 0108; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0101; 🇧🇬 Sofia, Bulgaria

Chiesi Clinical Trial Site 0201; 🇩🇪 Berlin, Germany

Chiesi Clinical Trial Site 0207; 🇩🇪 Radebeul, Germany

Chiesi Clinical Trial Site 0306; 🇮🇹 Brescia, Italy

Chiesi Clinical Trial Site 0303; 🇮🇹 Pordenone, Italy

Chiesi Clinical Trial Site 0208; 🇩🇪 Witten, Germany

Chiesi Clinical Trial Site 0501; 🇵🇱 Bialystok, Poland

Chiesi Clinical Trial Site 0512; 🇵🇱 Lodz, Poland

Chiesi Clinical Trial Site 0506; 🇵🇱 Zgierz, Poland