Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma

This is an interventional treatment trial for Asthma focused on measuring Asthma, Mometasone furoate, Inhalation devices, Forced expiratory volume Read More

Inclusion Criteria:

• A diagnosis of asthma for at least 6 months
• Baseline FEV1 must be > = 55% and < = 85% of predicted
• Increase in absolute FEV1 of >12%, with an absolute volume increase of at least 200 mL after reversibility testing
• Use of an adequate form of birth control by non-pregnant women of childbearing potential

• Absence of use of the following medication prior to the inclusion:

  • Beta 2 agonist short-acting (inhaled, oral)-12 Hours
  • Beta 2 agonist long-acting (inhaled)-48 Hours
  • Ipratropium bromide-12 hours
  • Cromolyn sodium, nedocromil-07 days
  • Astemizole-03 months
  • Cetotifeno-03 months
  • Another investigational drug-01 month
  • Theophyline-2 weeks
  • Antihistamines-07 days
  • Anticholinergics-07 days
  • Leukotriene modifiers-2 weeks
  • Oral decongestant long-acting-72 hours
  • Oral decongestant short-acting-24 hours

Exclusion Criteria:

• Women who were pregnant, breast-feeding, or are pre-menarcheal.
• Subjects who have used any investigational drug within the last 30 days
• Subjects who were receiving immunotherapy
• Subjects requiring the use of >12 puffs per day of Salbutamol on any 2 consecutive days
• Smokers or ex-smokers
• Subjects who are allergic to corticosteroids or beta-agonists
• Subjects who have required inpatient hospitalization for asthma control within the previous 3 months
• Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years
• Subjects who have been treated in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction, on two or more occasions within the last six months
• Subjects with clinical evidence of emphysema, chronic bronchitis, bronchiectasis, or cystic fibrosis
• Subjects with a significant history of renal, hepatic, cardiovascular, metabolic, neurologic, hematological, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could have interfered with the study, or required treatment which might have interfered with the study
• Subjects who have experienced an upper or lower respiratory tract infection (viral or bacterial) within the previous 2 weeks prior to enrollment
• Subjects who have clinically significant abnormalities on chest x-ray at the Screening Visit or within the previous year
• Subjects who are known to be HIV positive
• Subjects who are known to be illicit drug abusers
• Subjects with hypothalamic-pituitary-adrenal (HPA) axis disturbances
• Subjects with severe pulmonary airflow obstruction showing to be life-threatening characterized by cyanosis, confusion, somnolence, coma or tiredness, thorax silent to hearing or showing weak respiration,PEFR <25% of the predicted normal, bradycardia (heartbeats bellow 60 beats per minute)
• Subjects with baseline FEV1 < 55% of the predicted normal
• Subjects with uncontrolled hypertension
• Subjects with suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary tuberculosis, alpha-1 anti-trypsin deficiency, lung mycosis (blastomycosis, histoplasmic) or pulmonary cystic fibrosis
• Subjects with history of thoracic surgery or any previous malignancy of the lung
• Subjects with significant heart disease (e.g., previous acute myocardial infarction, angina pectoris, pulmonary edema or other cardiovascular disease which is characterized as life-threatening
• Subjects receiving beta-adrenergic blocking agents