Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone furoate; Concept 1; Twisthaler
Intervention description: Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device; A single dose dry powder inhaler (SDDPI); A single dose dry powder inhaler (SDDPI)
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 739.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      The purpose of this study is to compare the efficacy, safety and pharmacokinetics of
      Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and
      adolescent patients with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females who were ≥ 12 years old at the time informed consent was obtained

          -  Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who
             additionally met the following criteria

          -  Patients who were receiving ICS treatment up to the maximum dose per day as indicated
             in the corresponding package leaflet and also a stable ICS regimen for at least 4
             weeks prior to screening (Visit 2).

          -  Patients whose level of asthma control according to GINA 2010 guideline was "Partly
             Controlled" or "Uncontrolled" at screening (Visit 2).

          -  Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at
             screening (Visit 2).

          -  Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over
             prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol
             (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.

          -  Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

        Key exclusion criteria included:

          -  Patients diagnosed with COPD as defined by the Global Initiative for Chronic
             Obstructive Lung Disease, updated 2010.

          -  Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed
             by chest X-ray to be no longer active), or clinically significant bronchiectasis.

          -  Patients with any chronic conditions affecting the respiratory tract (e.g., chronic
             sinusitis) or chronic lung diseases, which in the opinion of the investigator may
             interfere with the study evaluation or optimal participation in the study.

          -  Patients with seasonal allergy which is likely to deteriorate his/her asthma condition
             during the study period judged by the investigator.

          -  Patients who have had a severe asthma attack/exacerbation requiring hospitalization in
             the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue
             from the trial (screening failure).

          -  Patients who have had an emergency room visit for an asthma attack/exacerbation within
             4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from
             the trial (screening failure).

          -  Patients who have ever required intubation for a severe asthma attack/exacerbation.

          -  Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1,
             or any time between Visit 1 and Visit 5 must discontinue from the trial (screening
             failure).

        Other protocol-defined inclusion/exclusion criteria may apply