Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone propionate/salmeterol; indacaterol maleate / mometasone furoate; placebo to indacaterol/mometasone; placebo to fluticasone propionate/salmeterol
Intervention description: Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.; Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.; Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.; Placebo to fluticasone propionate / salmeterol delivered via MDDPI.
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; QMF; Indacaterol; Mometasone

Summary:

      This study is designed to provide data about the 24 hours FEV1 profile, safety and
      tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using
      fluticasone/salmeterol as an active control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients aged 18-75 years (inclusive), who have signed an
             Informed Consent Form prior to initiation of any study-related procedure,

          -  Patients with persistent asthma, diagnosed according to Global Initiative for Asthma
             (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood
             Institute, 2006) and who additionally meet the following criteria:

               -  Patients receiving daily treatment with inhaled corticosteroid up to the maximum
                  dose per day indicated in the product label, in a stable regimen for the month
                  prior to Visit 1.

               -  Patients with an FEV1 at Visit 1 ≥50% of predicted normal.

               -  Patients who demonstrate an increase of ≥ 12% and ≥ 200 mL in FEV1 over their
                  pre-bronchodilator.

        Exclusion Criteria:

          -  Pregnant women, nursing mothers, or females of childbearing potential, regardless of
             whether or not sexually active, if they are not using a reliable form of
             contraception.

          -  Patients who have used tobacco products within the 6 months period prior to Visit 1,
             or who have a smoking history of greater than 10 pack years.

          -  Patients diagnosed with Chronic Obstructive Pulmonary disease (COPD) as defined by the
             GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2006).

          -  Patients with seasonal allergy whose asthma is likely to deteriorate during the study
             period.

          -  Patients who have had an acute asthma attack/exacerbation requiring hospitalization in
             the 6 months prior to Visit 1.

          -  Patients who have had an acute asthma attack / exacerbation requiring an emergency
             room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or
             at any time between Visit 1 and Visit 2.

          -  Patients with a history of long QT interval syndrome or whose QT interval corrected
             for heart rate (QTc) interval (Bazett's) measured at Visit 1 or Visit 2 is prolonged:
             > 450 ms (males) or > 470 ms (females).

          -  Other clinically significant conditions which may interfere with the study conduct or
             patient safety as specified in the protocol.

        Other protocol-defined inclusion/exclusion criteria may apply.