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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296411
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 5259 12.5 µg Drug: CHF 5259 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. 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 Measures :
  1. Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42 [ Time Frame: Day 42 ]

Other Outcome Measures:
  1. Adverse Events and Adverse Drug reactions [ Time Frame: Up to 17 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296411


Locations
Show Show 28 study locations
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02296411    
Other Study ID Numbers: CCD-05993AB1-02
2014-001442-16 ( EudraCT Number )
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Access Criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
URL: https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma, Anticholinergics
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Glycopyrrolate
Bromides
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs