study of qmf149 (150/80 µg) compared with mf twisthaler® (200 µg) in patients with asthma

Conditions: Mild Asthma

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.

the primary objective of this study was to demonstrate the superiority of qmf149 150/80 microgram o.d. (in the evening) delivered via concept1 compared with mf 200 microgram o.d. (in the evening) delivered via twisthaler® in terms of trough fev1 after 12 weeks of treatment in adults and adolescents. the key secondary objective of this study was to demonstrate the superiority of qmf149 150/80 microgram to mf 200 microgram o.d. in terms of acq-7 after 12 weeks of treatment.

Eligibility criteria:
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 or hospitalization (\> 24 hours) or emergency room visit (≤ 24 hours) as follows: * for adults: within 6 weeks of screening visit. if patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between visit 1 and visit 102 they may be re-screened 6 weeks after recovery from the exacerbation * for adolescents: severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, or hospitalization (\> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, or emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months. * patients who ever required intubation for a severe asthma attack/exacerbation * patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ics administration (according to investigator's medical judgment ) * patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to screening visit or between visit 1and visit 102. patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. * patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study. * patients with a history of chronic lung diseases other than asthma, including (but not limited to) copd, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. * patients with type i diabetes or uncontrolled type ii diabetes. * patients with narcolepsy and/or insomnia. * patients on maintenance immunotherapy (desensitization) for allergies or less than 3 months prior to visit 101 or patients on maintenance immunotherapy for more than 3 months prior to visit 101 but expected to change throughout the course of the study. * patients with diagnosed rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products. * patients who use a long acting muscarinic antagonist (lama) within 3 months prior to visit 1.

Keywords: phase iii, blinded, qmf149, mometasone furoate (mf), mild asthma, adolescent, adult