Intermittent and Daily Treatment for Episodic Asthma (IDEA)

Not Applicable

• Conditions: -J459 Asthma, unspecified; Asthma, unspecified; J459

• Registration Number: PER-086-06
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) The patient is a boy or girl from 2 years (24 months) to 5 years (71 months) of age.
b) The parent / legal guardian agrees that the patient participate in the study as indicated by the signature of the parent / legal guardian in the informed consent.
c) The patient has a history of episodic asthma symptoms, so that in the 12 months prior to Visit 1, the patient had at least 3 but no more than 6 symptoms of asthma episodes for approximately 3 days.
d) In the 12 months prior to Visit 1, the patient had at least one treatment with corticosteroids or was hospitalized at least 1 time because of asthma.
e) It is determined that in other aspects the patient is well, with stable health and seems to be able to successfully complete this test.
f) Parents / guardians are able to read and understand the questions that appear in the diary.
g) Patients can chew a tablet.

Exclusion Criteria

a) The parent / guardian is mentally or legally incapacitated, which prevents the signing of informed consent.
b) The patient is hospitalized.
c) The patient has participated in a clinical trial that involves a drug under investigation or commercialized within the 8 weeks prior to Visit 1.
d) The patient has had some major surgical procedure within 4 weeks prior to Visit 1.
e) The patient has some active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or has hypertension.
f) The patient has a history of some clinically significant adverse event of a serious nature related to the administration of any drug marketed or under investigation or, otherwise, is sensitive to drugs marketed or under investigation.
g) The patient presents significant or unexplained abnormalities in the physical examination of Visit 1
h) The patient has a history of persistent symptoms of asthma so that diurnal symptoms occur> once a week and nocturnal symptoms occur> twice a month.
i) The patient presents any acute or chronic active lung disorder, different from asthma, documented by history or physical examination.
j) The patient has required, in the past, intubation due to asthma.
k The patient has some unresolved sign or symptom of an acute episode of asthma in the last 2 weeks.
l) The patient has some sign or symptom of an infection of the respiratory tract in the last 2 weeks.
m) The patient has some evidence of active sinus disease, clinically important in the last 4 weeks.
n) The patient is receiving immunotherapy.
o) The patient has used long-term control drugs in the last 2 weeks or for> 4 months, cumulatively, in the 12 months prior to Visit 1.
p) The patient is in a situation or has a condition that may interfere with their optimal participation in the study.
q) The patient and / or the parent / guardian are unable or unwilling to comply with the study procedures.
r) The patient has significant or unexplained abnormalities in the laboratory safety tests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified