Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
With
Merck Sharp & Dohme LLC
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female adult patients aged 18-75 years with persistent asthma
Patients with persistent asthma, diagnosed according to the Global Initiative for Asthma guidelines (GINA) and who additionally met the following criteria:
1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50% of the predicted normal value. This criterion for FEV1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility test). Reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1 pre-dose value had to be at least 85% of the larger value.
Body mass index (BMI) between 18 and 32 kg/m\^2 and weight \>50 kg.
patients using local contraception
You may not be if
Pregnant or nursing women
Recent use of tobacco or history of smoking \> 10 pack years
Patients diagnosed with chronic obstructive pulmonary disease (COPD)
Patients with recent experience of severe asthma attack/exacerbation within 6-months of study start
Patients with frequent rescue medication (\>8 puffs/day for two consecutive days)
Clinically relevant laboratory abnormality or a clinically significant condition
Active cancer or a history of cancer with less than 5 years disease free survival time
History of long QT syndrome or with long QTc interval prior to dosing
History of hypersensitivity to the study drugs or to drugs with similar chemical structures
Use of certain medications
Use of other investigational drugs
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
History of immunodeficiency diseases, including a positive human immumodeficiency virus (HIV) test result.
History of drug or alcohol abuse or evidence of such abuse
Clareo Health | Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
