Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma (NCT02892344) | Clinical Trial Compass
CompletedPhase 3
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Bulgaria, Chile802 participantsStarted 2017-01-16
Plain-language summary
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
* Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
* Adult patients who are symptomatic at screening despite treatment with existing therapy.
Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
* Adolescent patients :
* If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
* If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and \<1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
* Pre-bronchodilator FEV1≥ 60 % and \< 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102
* Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
Exclusion Criteria:
* Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
* Patients who have had an asthma attack/exacerbation requiring systemic steroids o…