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NCT02296411 Clinical Trial

Efficacy of LAMA Added to ICS in Treatment of Asthma

Asthma Clinical Trial

— ELITRA  

Official title:
A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02296411
Other study ID # CCD-05993AB1-02
Secondary ID 2014-001442-16
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2014
Est. completion date August 2015

Study information
Verified date April 2021
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CHF 5259 12.5 µg
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
• CHF 5259 placebo
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks

Locations
Country Name City State
Bulgaria Chiesi Clinical Trial Site 0107 Ruse
Bulgaria Chiesi Clinical Trial Site 0106 Sevlievo
Bulgaria Chiesi Clinical Trial Site 0101 Sofia
Bulgaria Chiesi Clinical Trial Site 0102 Sofia
Bulgaria Chiesi Clinical Trial Site 0103 Sofia
Bulgaria Chiesi Clinical Trial Site 0108 Sofia
Bulgaria Chiesi Clinical Trial Site 0109 Sofia
Germany Chiesi Clinical Trial Site 0201 Berlin
Germany Chiesi Clinical Trial Site 0202 Leipzig
Germany Chiesi Clinical Trial Site 0203 Leipzig
Germany Chiesi Clinical Trial Site 0206 Magdeburg
Germany Chiesi Clinical Trial Site 0207 Radebeul
Germany Chiesi Clinical Trial Site 0208 Witten
Italy Chiesi Clinical Trial Site 0306 Brescia
Italy Chiesi Clinical Trial Site 0301 Pisa
Italy Chiesi Clinical Trial Site 0304 Pisa
Italy Chiesi Clinical Trial Site 0303 Pordenone
Netherlands Chiesi Clinical Trial Site 0404 Assen
Netherlands Chiesi Clinical Trial Site 0405 Helmond
Poland Chiesi Clinical Trial Site 0501 Bialystok
Poland Chiesi Clinical Trial Site 0502 Bialystok
Poland Chiesi Clinical Trial Site 0503 Elblag
Poland Chiesi Clinical Trial Site 0504 Krakow
Poland Chiesi Clinical Trial Site 0507 Krakow
Poland Chiesi Clinical Trial Site 0510 Lodz
Poland Chiesi Clinical Trial Site 0512 Lodz
Poland Chiesi Clinical Trial Site 0505 Wroclaw
Poland Chiesi Clinical Trial Site 0506 Zgierz

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Bulgaria,  Germany,  Italy,  Netherlands,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Other Adverse Events and Adverse Drug reactions Up to 17 Weeks
Primary 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 Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42 Day 42
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