BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg])

ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChiesi Farmaceutici S.p.A.

About this trial

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.

Eligibility criteria

Qualifiers

None

Disqualifiers

Participation in another interventional clinical trial.

Pregnant or breastfeeding women at the moment of enrolment.

Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled/clinically significant diseases (according to investigator's judgement).

Contraindication for LAMA use.

Trial design

Treatments tested in this trial

  • Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
  • Foster® 200/6 pMDI (BDP/FF-200/6 µg)

Treatment groups

644 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators