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

April 6, 2021 updated by: Chiesi Farmaceutici S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Chiesi Clinical Trial Site 0107
      • Sevlievo, Bulgaria, 5400
        • Chiesi Clinical Trial Site 0106
      • Sofia, Bulgaria, 1000
        • Chiesi Clinical Trial Site 0101
      • Sofia, Bulgaria, 1336
        • Chiesi Clinical Trial Site 0109
      • Sofia, Bulgaria, 1407
        • Chiesi Clinical Trial Site 0108
      • Sofia, Bulgaria, 1431
        • Chiesi Clinical Trial Site 0102
      • Sofia, Bulgaria, 1431
        • Chiesi Clinical Trial Site 0103
  • Germany
      • Berlin, Germany, D-12165
        • Chiesi Clinical Trial Site 0201
      • Leipzig, Germany, 04207
        • Chiesi Clinical Trial Site 0203
      • Leipzig, Germany, 04357
        • Chiesi Clinical Trial Site 0202
      • Magdeburg, Germany, 39112
        • Chiesi Clinical Trial Site 0206
      • Radebeul, Germany, 01445
        • Chiesi Clinical Trial Site 0207
      • Witten, Germany, 58452
        • Chiesi Clinical Trial Site 0208
  • Italy
      • Brescia, Italy, 25123
        • Chiesi Clinical Trial Site 0306
      • Pisa, Italy, 56124
        • Chiesi Clinical Trial Site 0301
      • Pisa, Italy, 56124
        • Chiesi Clinical Trial Site 0304
      • Pordenone, Italy, 33170
        • Chiesi Clinical Trial Site 0303
  • Netherlands
      • Assen, Netherlands, 9401 RK
        • Chiesi Clinical Trial Site 0404
      • Helmond, Netherlands, 5707 HA
        • Chiesi Clinical Trial Site 0405
  • Poland
      • Bialystok, Poland, 15-010
        • Chiesi Clinical Trial Site 0501
      • Bialystok, Poland, 15-351
        • Chiesi Clinical Trial Site 0502
      • Elblag, Poland, 82-300
        • Chiesi Clinical Trial Site 0503
      • Krakow, Poland, 30-349
        • Chiesi Clinical Trial Site 0507
      • Krakow, Poland, 31-011
        • Chiesi Clinical Trial Site 0504
      • Lodz, Poland, 90-141
        • Chiesi Clinical Trial Site 0512
      • Lodz, Poland, 90-252
        • Chiesi Clinical Trial Site 0510
      • Wroclaw, Poland, 53-310
        • Chiesi Clinical Trial Site 0505
      • Zgierz, Poland, 95-100
        • Chiesi Clinical Trial Site 0506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 5259 12.5 µg
CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)
Drug: CHF 5259 12.5 µg
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
Other Names:
  • glycopyrrolate bromide
Placebo Comparator: CHF 5259 placebo
CHF 5259 placebo: 2 inhalations bid
Drug: CHF 5259 placebo
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42
Time Frame: Day 42
Day 42

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Events and Adverse Drug reactions
Time Frame: Up to 17 Weeks
Up to 17 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-05993AB1-02
  • 2014-001442-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD Sharing Access Criteria

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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