None listed
Conditions
Interventions
Group 1 Type of group
200 ug of salbutamol administered by the pMDI device plus placebo administered on demand through the MDDPI device for 12 weeks and then maintenance with formoterol at 10 ug b.i.d. administered through the MDDPI device plus formoterol on demand administered through the MDDPI device
Group name:Group 2 Type of group
Placebo administered by the MDDPI device plus 10 ug of formoterol administered on demand through the MDDPI device for 12 weeks and then maintenance with formoterol at 10 ug b.i.d. administered through the MDDPI device plus salbutamol on demand administered through the pMDI device
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory patients, men or women, aged between 13 and 75 years, inclusive. • Written informed consent granted by the patient or by a family member or his / her legally authorized guardian / representative. • Patients with persistent asthma who present symptoms weekly, with at least one day free of symptoms during the run-in period. • FEV1 with a value between 50-79% (inclusive) of the expected. • Reversibility documented within the last 12 months, or reversibility demonstrated in Visit 1, 15% or more in FEV1, 30 minutes after inhaling 400 pg of salbutamol. • Patients receiving anti-inflammatory treatment for stable asthma during the month prior to Visit 1, and during the run-in period.
Exclusion criteria
Exclusion criteria: • Pregnant women, who breastfeed, or who are of childbearing age and do not practice an acceptable method of contraception (oral, mechanical, subcutaneous or surgical). Any patient who becomes pregnant during the trial must interrupt their participation in it and must be controlled during pregnancy and up to 12 months after giving birth. • A respiratory infection within the month prior to Visit 1. Patients who develop a respiratory tract infection during the run-in period should discontinue the trial, but will be allowed to be re-recruited at a later date (at least 1 month after the resolution of the respiratory tract infection). • An exacerbation of documented asthma within 4 weeks prior to Visit 1. • Clinically relevant diseases (including cardiovascular diseases, arrhythmias, uncontrolled hypertension, hypo and hyperthyroidism, hyperadrenergic state, insulin-dependent diabetes mellitus, neoplasms, and laboratory profiles with pathological significance) The trial of the investigator or staff responsible for Novartis may compromise the safety or adherence of the patient, interfere with the evaluations, or prevent the completion of the trial. • Patients with COPD, or patients with a history of smoking of> 10 cartons of cigarettes / year (that is, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, etc.). • QTc above 0.46 seconds in Visit 1 or 2. • A documented result of potasemia below the normal range, obtained in the central laboratory at Visit 1 or, if the result of the central laboratory is not available, a result of a local laboratory at Visit 2. • Any antiallergic immunization treatment (desensitization) within the last 6 months. • History of adverse reactions to sympathomimetic amines or medication administered by inhalation or any of its components. • History of non-adherence to therapeutic regimens and patients considered potentially untrustworthy. • History of alcoholism and / or a history of drug addiction. • Treatment with any investigational drug within the month prior to Visit 1. • Use of nasal or inhaled corticosteroids, cromoglycate, nedocromil or leukotriene receptor antagonists that have been used or discontinued or are subject to any change in the daily dose or administration schedule in the month prior to the visit 1. Patients who require the institution of treatment with these medications during the run-in period will not be randomized. Patients can be re-evaluated once they remain under stable treatment for 1 month. • The following medications should not be used between Visit 1 and Visit 7 (except in case of exacerbations). The minimum wash-out periods for use before Visit 1, are detailed below: Oral or parenteral corticosteroids: 1 month, Theophylline (any pharmaceutical form): 72 hours, Anti-cholinergic by inhalation or mouth : 48 hours, long-acting p2 agonists by inhalation or mouth: 4 hours. • Other medications excluded: p-blocking agents, quinidine and quinidine-like medications (antiarrhythmics), tricyclic antidepressants or other antidepressants (eg, Prozac®, Zoloft®, etc.), and monoamine oxidase inhibitors, of the month prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Average of the last 30 daily records available of the on-demand use of the masked medication during the first 3 months of treatment Measure:On-demand use of the masked medication Timepoints:3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Review of daily records Measure:Use of rescue medication at a known dose (salbutamol) Timepoints:After the treatment ; Outcome name:FEV1 predose at the center Measure:FEV1 predose obtained at the center of the study Timepoints:During treatment ; Outcome name:Review of daily records Measure:Record of the asthma nocturnal symptoms score of the patients diary Timepoints:At the end of the study ; Outcome name:Review of daily records Measure:Record of asthma daytime symptom score of patient diary Timepoints:At the end of the study ; Outcome name:Review of daily records Measure:Time elapsed until the first exacerbation Timepoints:At the end of the study ; Outcome name:Review of daily records Measure:Number of exacerbations Timepoints:At the end of the study | — |
Outcome results
None listed