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

Mantercorp

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Device: OXIMAX

Device: ASMANEX TWISTHALER

Study type

Interventional

Funder types

Industry

Identifiers

NCT00975741

ASM/P/01/1

Details and patient eligibility

About

Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

Full description

Background: Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. Results of laboratory analysis for respirable fraction, content uniformity of emitted dose and of the bulk powder and for percentage of particles < 1 micra of both MF 200 µg and MF 400 µg capsules have indicated their equivalent performance in comparison to MF DPI multidose.

Aim: The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

Methods: Ninety-seven adult patients with moderate persistent asthma were randomized in two groups to receive for 60 days a dose of 400 µg of DPI MF once daily (at evening) using multidose or monodose device. Follow-up visits were scheduled at Days 7, 14, 28, 42 and 56. Efficacy was assessed by means of pulmonary function tests (spirometry - FEV1 and PEFR) at each visit. In addition, subjects have recorded twice daily PEFR, symptom scores and use of rescue medication throughout the study. Response to therapy was also assessed. Safety evaluations included monitoring of adverse events, vital signs, clinical laboratory tests (plasma cortisol concentrations were assessed at enrollment and repeated after 60 days of MF treatment; cortrosyn test was performed at the enrollment and after 60 days of MF treatment), and physical examination.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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