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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 : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 8, 2016
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE April 6, 2016
Actual Primary Completion Date May 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Pre-dose FEV1 (Forced Expiratory Volume in the first second) [ Time Frame: Week 26 ]
  • Reduction of moderate and severe asthma exacerbations rate [ Time Frame: Week 0 to Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02676089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose [ Time Frame: Week 26 ]
  • Change from baseline in morning PEF (Peak Expiratory Flow) [ Time Frame: Week 0 to Week 26 ]
  • Reduction of severe asthma exacerbations rate [ Time Frame: Week 0 to week 52 ]
    Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Adverse Events and Adverse Drug reactions [ Time Frame: Up to Week 52 ]
  • Collection of Health Economics outcomes [ Time Frame: Week 0 to Week 52 ]
    Total use of healthcare resources and absence from work
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms
  • 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

    Intervention: 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

    Intervention: 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

    Intervention: Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2018)
1433
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
1435
Actual Study Completion Date May 28, 2018
Actual Primary Completion Date May 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belarus,   Bulgaria,   Czechia,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02676089
Other Study ID Numbers  ICMJE CCD-05993AB2-02
2015-000717-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georgio Walter Canonica, MD University of Medicine, Genoa, Italy
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP