A Multicenter, Double-BIind, Randomized, Parallel-Group Study Comparing the Effect of Linear Growth of Monteiukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepuberal, Tanner Stage I) With Mild Asthma
- Conditions
- -J458 Mixed asthmaMixed asthmaJ458
- Registration Number
- PER-018-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• General
• The patient is a man between 6 and 8 years of age, inclusive, or a woman between 6 and 7 years of age, inclusive.
• The patient is in Stage I according to Tanner in Visit 1.
• The patient is within the 5 to 95 percentile for the range of height and the weight range according to age according to the percentiles of the National Center for Health Statistics for men and women with ages of 2 to 18 years.
• The parent / legal guardian and the patient accept the patient´s participation in the study as indicated by the signature of the parent / legal guardian on the consent form and the patient´s signature in the approval form, respectively. The patient and the parent / guardian are willing to comply with the procedures and both the patient and the parent / guardian can follow the scheduled clinic visits.
• The patient´s bone age (based on the X-rays of the left hand and wrist in Visit 1) is + 1 year of the chronological age of the patient.
• It is considered that the patient is otherwise in good physical condition according to the medical history, the physical examination and the usual laboratory information.
• Parents / guardians can read and understand the baseline asthma questionnaire and the asthma calendar.
• Pulmonary
• The patient has a history of asthma whose duration is at least 6 months with typical symptoms, including, but not limited to, coughing, wheezing and shortness of breath, with periodic episodes requiring treatment with inhaled p-agonists.
• The patient has, while the use of p-agonists is suspended for a minimum of 6 hours and antihistamines for at least 48 hours, a FEV1 of> 80% of the predicted, documented in Visits 1 and 2.
• The patient has persistent mild asthma in Step 2 of the GINA guidelines as demonstrated by the parent / guardian´s response to the letter b for each of the three questions in the Baseline Asthma Questionnaire.
• The patient can perform a reproducible pulmonary function test.
General
• In the opinion of the investigator, the patient is mentally or legally incapacitated.
• In the opinion of the investigator, the parent / guardian is mentally or legally incapacitated, which prevents the obtaining of informed consent.
• The patient is hospitalized.
• The patient has participated in a previous clinical trial.
• The patient has undergone some important surgical procedure within 4 weeks before Visit 1.
• Pulmonary
• The patient has a severe chronic sinus disease or nasal polyposis.
• The patient has some active or acute or chronic lung disease or disease, other than asthma, documented by a history or a physical examination.
• The patient has required intubation for asthma in the past.
• The patient has had to go to an emergency due to an asthma exacerbation or has been hospitalized for asthma within 4 months before Visit 1.
• The patient has unresolved signs and symptoms of an upper or lower respiratory tract infection or has had an upper or lower respiratory tract infection within 3 weeks before Visit 1.
General Practitioners
• The patient has a history of surgical ablation, radiation or tumor of the pituitary or hypothalamus.
• The patient has ever been diagnosed with cancer, diabetes, kidney failure, chronic inflammatory disease (with the exception of asthma) or panhypopituitarism.
• The patient has a history of thyroid disease.
• The patient has a history of any clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or suffers from hypertension (> 130/90 mm Hg).
• The patient has a history of some clinically significant adverse experience of a serious nature related to the administration of a commercialized or investigational drug (eg, angioedema, anaphylaxis) or is otherwise sensitive to montelukast (or other antagonists of the leukotriene receptors), inhaled beclomethasone, inhaled P-agonist or its components.
• The patient has a history of a disease that would require treatment with an excluded medicine, which could immediately threaten his life (for example: arrhythmias, congenital heart disease), which would represent a restriction for the participation or successful completion of the study or that would represent a risk additional for the administration of inhaled montelukast or beclomethasone thereto.
• The patient has significant or unknown abnormalities in the physical examination and / or laboratory safety tests of Visit 1 (Appendices 12 and 13).
• The patient begins to menstruate at Visit 4 or before the visit (randomization visit.
• The patient has lost 9 or more consecutive days of treatment with the study drug during Period 1.
• The patient has some more advanced characteristic (s) than Stage I according to Tanner in Visit 4 (randomization visit).
• The patient has an increase in height from Visit 1 to 4 of less than 10 mm.
Previous / Concurrent Medications
• The patient has used one month or more of continuous treatment with montelukast (or other antileukotriene agents) or has used a month or more of continuous treatment with inhaled, intranasal, oral, intramuscular and / or intravenous corticosteroids.
• The patient has used montelukast (or other antileukotriene agents) within 4 months of Visit 1 or has used inhaled, intranasal, oral, intramuscular and / or intravenous corticosteroids within 4 months pr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:In this study, the efficacy endpoints<br>exploratory will be the following: (a) change with respect to the baseline in the FEVi; (b) days without the use of p-agonist; (c) discontinuations of blind study therapy due to worsening asthma; (d) rescue therapies with oral corticosteroids for the worsening of asthma; (e) total eosinophil counts in peripheral blood<br>Measure:Efficacy<br>Timepoints:After the administration of treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Adverse events will be recorded in the Adverse Event Case Report Forms.<br>Measure:Safety<br>Timepoints:During the administration of treatment<br>