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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2021 |
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Main ID: |
NCT02676089 |
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Date of registration:
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03/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
TRIGGER |
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Scientific title:
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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 |
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Date of first enrolment:
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April 6, 2016 |
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Target sample size:
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1433 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02676089 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Belarus
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Bulgaria
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Czechia
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Germany
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Hungary
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Italy
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Lithuania
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Poland
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Portugal
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Romania
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Russian Federation
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Slovakia
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Spain
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Turkey
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Ukraine
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United Kingdom
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Contacts
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Name:
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Georgio Walter Canonica, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine, Genoa, Italy |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: CHF 5993 200/6/12.5 µg
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Drug: CHF 1535 200/6 µg
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Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
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Primary Outcome(s)
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Reduction of moderate and severe asthma exacerbations rate
[Time Frame: Week 0 to Week 52]
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Pre-dose FEV1 (Forced Expiratory Volume in the first second)
[Time Frame: Week 26]
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Secondary Outcome(s)
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Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
[Time Frame: Week 26]
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Change from baseline in morning PEF (Peak Expiratory Flow)
[Time Frame: Week 0 to Week 26]
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Reduction of severe asthma exacerbations rate
[Time Frame: Week 0 to week 52]
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Secondary ID(s)
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2015-000717-40
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CCD-05993AB2-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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