Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
- Conditions
- -J45J45
- Registration Number
- PER-104-08
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Before any evaluation is conducted, the parents / legal guardian and the child, if possible, must give written informed consent. They must also be able to adhere to the dosing schedules and visits and meet the study requirements.
• In the selection, the child must be 5 to 11 years old, of any sex and of any race.
• A diagnosis (according to the GINA guidelines) of persistent asthma for a period of at least 6 months before screening and must have been on a stable asthma regimen (daily dose unchanged) at least 4 weeks before the selection.
• Reversibility with p2 agonist »defined as an increase in absolute FEV1 of> 12% within 30 minutes after the administration of 200 ug of salbutamol without the use of a spacer or its equivalent according to the standards of the ATS / ERS in the selection (Visit l) / optional selection visit (Visit lA).
• In the selection (Visit I) / optional screening visit (Visit 1 A), the child must have a FEV1> 60% and <90% of the predicted by Polgar when all the restricted medications have been suspended during the appropriate intervals.
• The child must be able to demonstrate his / her ability to use the pMDI and DPI inhalers correctly and must demonstrate his / her ability to perform reproducible expiratory maneuvers in accordance with ATS / ERS standards
• A patient requiring the use of a spacer device to compensate for poor hand-breathing coordination with a pMDI inhaler.
• Use of other investigational drugs at the time of recruitment, or within 30 days or 5 half-lives of recruitment, whichever is longer.
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures (to IOS, p2 agonists or similar agents or any of the components of the study medications). Patients with a history of negative reactions to sympathomimetic amines or inhaled medication or any component of these. Adverse reaction or allergy to the drug albuterol, prednisone, prednisolone or methylprednisolone.
• History of malignancy in any organ system, treated or not treated in the last 5 years whether or not there is evidence of local recurrence or metastasis.
• A patient who demonstrates, in Visit 2, a pre-dose change (increase or decrease) in absolute FEV1> 15% compared to the FEV1 value obtained in the selection.
• A patient requiring the use of> 8 inhalations per day of salbutamol 100 ug per pMDI performance, or> 2 nebulized treatments per day of 1.25 mg of salbutamol (or its equivalent), or in the case that the patient´s symptoms require that he / she takes 8 puffs / day of rescue medication for more than 2 consecutive days between Visits 1 and 2.
• A patient who has been hospitalized or has received treatment in the emergency room for an acute exacerbation of asthma in the month prior to Visit 1 or who experiences clinical deterioration of asthma, judged by the clinical investigator in that way, among the Visits 1 and 2, which result in emergency treatment, hospitalization due to asthma, or additional treatment with an excluded asthma medication (other than SABA).
• A patient with a significant medical condition or situation, including cardiovascular diseases, such as congenital heart defects and acquired cardiac diseases (arrhythmias, etc.), hypo and hyperthyroidism, hyperadrenergic conditions, diabetes mellitus, abnormal laboratory profile, renal or hepatic dysfunction known, exposure to chicken pox in the last 21 days or any condition that could compromise the safety of the patient, patient compliance, interfere with the evaluations, or prevent the completion of the trial that is not the condition being studied that, in opinion of the researcher, could interfere with the evaluation of the study or with the optimal participation in the study.
• A patient with a QTc> 440 msec for children or a QTc> 450 msec for girls on an electrocardiogram (ECG) evaluation in the selection.
• An ECG performed on the selection that is not clinically acceptable to the researcher.
• A patient who has suffered a high or low respiratory tract infection within 4 weeks prior to screening. Patients who developed a respiratory tract infection during the period of admission should be discontinued from the study, but will be allowed to re-enroll at a later date and at least 4 weeks after the resolution of a respiratory tract infection.
• Children with any chronic condition that affects the respiratory tract (eg,
• Chronic sinusitis) or chronic lung diseases such as cystic fibrosis, which in the opinion of the investigator may interfere with the evaluation of the study or the optimal participation of the study.
• Patients who do not maintain day / night cycles, awake / asleep.
• Patients with a history of noncompliance with medical regimens and
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose<br><br>Measure:The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment<br><br>Timepoints:From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment)<br>
- Secondary Outcome Measures
Name Time Method