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TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER) (TRIGGER)

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ClinicalTrials.gov Identifier: NCT02676089
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 5993 200/6/12.5 µg Drug: CHF 1535 200/6 µg Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT® IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS
Actual Study Start Date : April 6, 2016
Actual Primary Completion Date : May 28, 2018
Actual Study Completion Date : May 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CHF 5993 200/6/12.5 µg

Treatment A:

CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB

 Drug: CHF 5993 200/6/12.5 µg
Active Comparator: CHF 1535 200/6 µg

Treatment B:

CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF

 Drug: CHF 1535 200/6 µg
Active Comparator: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Treatment C (open-label arm):

CHF 1535 200/6 µg: 2 inhalations bid

+ Tiotropium Respimat 2.5 µg: 2 inhalations od Total daily dose: 800/24 µg BDP/FF + 5 µg Tio

 Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg


Outcome Measures
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Primary Outcome Measures :
  1. Pre-dose FEV1 (Forced Expiratory Volume in the first second) [ Time Frame: Week 26 ]
  2. Reduction of moderate and severe asthma exacerbations rate [ Time Frame: Week 0 to Week 52 ]

Secondary Outcome Measures :
  1. Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose [ Time Frame: Week 26 ]
  2. Change from baseline in morning PEF (Peak Expiratory Flow) [ Time Frame: Week 0 to Week 26 ]
  3. Reduction of severe asthma exacerbations rate [ Time Frame: Week 0 to week 52 ]
    Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials


Other Outcome Measures:
  1. Adverse Events and Adverse Drug reactions [ Time Frame: Up to Week 52 ]
  2. Collection of Health Economics outcomes [ Time Frame: Week 0 to Week 52 ]
    Total use of healthcare resources and absence from work


Eligibility Criteria
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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 ≥ 1 year and diagnosed before 40 years old
  • Uncontrolled asthma with double therapy only on high doses of Inhaled CorticoSteroid (ICS) in combination with Long-Acting Beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
  • Pre-bronchodilator FEV1 <80% of the predicted normal value
  • Positive reversibility test
  • At least 1 documented asthma exacerbation in the previous year

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
  • Current smoker or ex-smoker (>= 10 packs year)
  • Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening
Contacts and Locations
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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): NCT02676089


Locations
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Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Georgio Walter Canonica, MD University of Medicine, Genoa, Italy
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02676089    
Other Study ID Numbers: CCD-05993AB2-02
2015-000717-40 ( EudraCT Number )
First Posted: February 8, 2016    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, Triple combination
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
Tiotropium Bromide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action