Last updated on November 2019

A Multicenter Randomized 52 Week Treatment Double-blind Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: Between 12 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
  • Patients who have used medium or high dose ICS or low dose of LABA/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
  • Patients must have ACQ-7 score 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
  • Pre-bronchodilator 50% FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators at both Visit 101 and 102, according to ATS/ERS criteria.
  • Withholding period of bronchodilators prior to spirometry: SABA for 6 hours and FDC or free combinations of ICS/LABA for 48 hours, SAMA for 8 hours, xanthines >=07 days
  • A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 g salbutamol/360 g albuterol (or equivalent dose) at Visit 101 All patients must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

  • Reversibility should be repeated once-
  • Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
  • Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

  • Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
  • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
  • Patients who have ever required intubation for a severe asthma attack/exacerbation.
  • Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
  • Patients who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
  • 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 severe narcolepsy and/or insomnia.
  • Patients who have a clinically significant ECG abnormality at Visit 101 (Start of RunIn epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
  • Patients with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
  • Patients who have not achieved an acceptable spirometry results at Visit 101 in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the patient fails the repeat assessment, the patient may be rescreened once

  • 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.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
  • LAMA use within 3 months prior to Visit 101

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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