Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

Asthma Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968201
• Other study ID #: 0476-072
• Secondary ID: 2009_651
• Status: Completed
• Phase: Phase 3
• Start date: December 1997
• Est. completion date: March 2001

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: March 2001
• Est. primary completion date: March 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Patient has history of physician diagnosed asthma

• Patient is in otherwise good stable health

• Patient is able to chew a tablet

Exclusion Criteria:

• Patient is hospitalized

• Patient and/or parent of guardian intends to move or vacation away from home during the course of the study

• Patient had any major surgical procedure within 4 weeks before the study

• Patient had active sinus disease within 3 weeks before the study

• Patient had required intubation for asthma in the past

• Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study

• Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
• Comparator: Placebo
one chewable placebo tablet, once daily at bedtime for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	12 weeks of treatment
Secondary	Number of Patients With Drug-related CAEs Reported by Patients - Base Study	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs	12 weeks of treatment
Secondary	Number of Patients With Serious CAEs Reported by Patients - Base Study	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	12 weeks of treatment
Secondary	Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study	Patients who reported serious drug-related CAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients Who Were Discontinued Due to CAEs - Base Study	Patients who were discontinued due to CAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study	Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study	Patients who were discontinued due to serious CAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	12 weeks of treatment
Secondary	Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs	12 weeks of treatment
Secondary	Number of Patients Who Were Discontinued Due to LAEs - Base Study	Patients who were discontinued due to LAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study	Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment	12 weeks of treatment
Secondary	Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	up to 2.8 years
Secondary	Number of Patients With Drug-related CAEs Reported by Patients - Extension	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs	up to 2.8 years
Secondary	Number of Patients With Serious CAEs Reported by Patients - Extension	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	up to 2.8 years
Secondary	Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension	Patients who reported serious drug-related CAEs up to 2.8 years of; treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to CAEs - Extension	Patients who were discontinued due to CAEs up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension	Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Serious CAEs - Extension	Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension	Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	up to 2.8 years
Secondary	Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs	up to 2.8 years
Secondary	Number of Patients With Serious LAEs - Extension	Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	up to 2.8 years
Secondary	Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension	Patients who reported serious drug-related LAEs up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to LAEs - Extension	Patients who were discontinued due to LAEs up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension	Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Serious LAEs - Extension	Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment	up to 2.8 years
Secondary	Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension	Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment	up to 2.8 years