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

NCT02296411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-04-22

Study results available
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Summary

Primary objective

The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide \[GB\]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42.

Key secondary objective

The key secondary objective was to evaluate the superiority of CHF 5259 pMDI (50 μg total daily dose) versus placebo in terms of peak FEV1 on Day 42.

Secondary objectives

The secondary objectives were:

* To evaluate the effect of CHF 5259 pMDI on other lung function parameters and on clinical outcome measures;
* To assess the safety and tolerability of study medications.

Conditions

Interventions

DRUG

CHF 5259 12.5 µg + Qvar

comparison of CHF 5259 versus placebo over 2 treatment periods of 6 weeks ± 2 days

DRUG

CHF 5259 placebo + Qvar

comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks ± 2 days

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • prof. Pierluigi Paggiaro, MD · Dip. Cardio-Toracico e Vascolare Malattie dell'Apparato respiratorio, Ospedale Cisanello, Pisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-21
Primary Completion
2015-08-13
Completion
2015-08-13

Countries

  • Bulgaria
  • Germany
  • Italy
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296411 on ClinicalTrials.gov