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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CHF 5259 12.5 µg
CHF 5259 placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Anticholinergics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiesi Clinical Trial Site 0107
  • Chiesi Clinical Trial Site 0106
  • Chiesi Clinical Trial Site 0101
  • Chiesi Clinical Trial Site 0109
  • Chiesi Clinical Trial Site 0108
  • Chiesi Clinical Trial Site 0102
  • Chiesi Clinical Trial Site 0103
  • Chiesi Clinical Trial Site 0201
  • Chiesi Clinical Trial Site 0203
  • Chiesi Clinical Trial Site 0202
  • Chiesi Clinical Trial Site 0206
  • Chiesi Clinical Trial Site 0207
  • Chiesi Clinical Trial Site 0208
  • Chiesi Clinical Trial Site 0306
  • Chiesi Clinical Trial Site 0301
  • Chiesi Clinical Trial Site 0304
  • Chiesi Clinical Trial Site 0303
  • Chiesi Clinical Trial Site 0404
  • Chiesi Clinical Trial Site 0405
  • Chiesi Clinical Trial Site 0501
  • Chiesi Clinical Trial Site 0502
  • Chiesi Clinical Trial Site 0503
  • Chiesi Clinical Trial Site 0507
  • Chiesi Clinical Trial Site 0504
  • Chiesi Clinical Trial Site 0512
  • Chiesi Clinical Trial Site 0510
  • Chiesi Clinical Trial Site 0505
  • Chiesi Clinical Trial Site 0506

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHF 5259 12.5 µg

CHF 5259 placebo

Arm Description

CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)

CHF 5259 placebo: 2 inhalations bid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2014
Last Updated
April 6, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02296411
Brief Title
Efficacy of LAMA Added to ICS in Treatment of Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Anticholinergics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5259 12.5 µg
Arm Type
Experimental
Arm Description
CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)
Arm Title
CHF 5259 placebo
Arm Type
Placebo Comparator
Arm Description
CHF 5259 placebo: 2 inhalations bid
Intervention Type
Drug
Intervention Name(s)
CHF 5259 12.5 µg
Other Intervention Name(s)
glycopyrrolate bromide
Intervention Description
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
Intervention Type
Drug
Intervention Name(s)
CHF 5259 placebo
Other Intervention Name(s)
Placebo
Intervention Description
comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42
Time Frame
Day 42
Other Pre-specified Outcome Measures:
Title
Adverse Events and Adverse Drug reactions
Time Frame
Up to 17 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chiesi Clinical Trial Site 0107
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0106
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0101
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0109
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0108
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0102
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0103
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0201
City
Berlin
ZIP/Postal Code
D-12165
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0203
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0202
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0206
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0207
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0208
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0306
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0301
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0304
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0303
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0404
City
Assen
ZIP/Postal Code
9401 RK
Country
Netherlands
Facility Name
Chiesi Clinical Trial Site 0405
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Chiesi Clinical Trial Site 0501
City
Bialystok
ZIP/Postal Code
15-010
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0502
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0503
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0507
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0504
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0512
City
Lodz
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0510
City
Lodz
ZIP/Postal Code
90-252
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0505
City
Wroclaw
ZIP/Postal Code
53-310
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0506
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-001442-16
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

Efficacy of LAMA Added to ICS in Treatment of Asthma

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