TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT02676076
• Date of registration: 03/02/2016
• Prospective Registration: Yes
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA TRIMARAN
• Scientific title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG ACTING ß2 AGONISTS
• Date of first enrolment: February 17, 2016
• Target sample size: 1153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02676076
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Christian Virchow, MD
• Affiliation: Facharzt für Innere Medizin Rostock, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- History of asthma = 1 year and diagnosed before 40 years old

- Uncontrolled asthma with double therapy only on medium 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 or ex-smokers (>= 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

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: CHF 1535 100/6 µg

Drug: CHF 5993 100/6/12.5 µg

Primary Outcome(s)

Reduction of moderate and severe asthma exacerbations rate [Time Frame: Week 0 to Week 52]

Pre-dose FEV1 (Forced Expiratory Volume in the first second) [Time Frame: at Week 26]

Secondary Outcome(s)

Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose [Time Frame: at Week 26]

Reduction of severe asthma exacerbations rate [Time Frame: Week 0 to Week 52]

Change from baseline in morning PEF (Peak Expiratory Flow) [Time Frame: Week 0 to Week 26]

Secondary ID(s)

2015-000716-18

CCD-05993AB1-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors