A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

Phase 3

• Conditions: Asthma in Infants and Children

• Registration Number: CTRI/2011/091/000069
• Lead Sponsor: MAP Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.This trial is ongoing in the United States and is listed on Clinicaltrials.gov (ID noted in Secondary ID section above).

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

*Male or female asthmatic children with mild to moderate persistant asthma.*12 months to 8 years of age.*For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.*For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted >1 day and affected sleep.*AND with at least one major or two minor risk factors.

Exclusion Criteria

*Any other significant childhood illness/abnormality or chronic lung disease.*Any history of upper or lower respiratory tract infection, within 2 weeks of screening.*Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.*Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.*Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the change from baseline in nighttime and daytime composite symptom scores.	Time Frame: Prospective

Secondary Outcome Measures

Name	Time	Method
To evaluate the change in clinic FEV1 from baseline.	Time Frame: Prospective
To evaluate e-diary symptoms (cough, wheeze, breathlessness)	Time frame: prospective
To evaluate lung function (PEF)	Time Frame: Prospective

Trial Locations

Locations (11)

Asthma Allergy Centre; 🇮🇳 Colony, India

Athmeya Polyclinic & Diagnostic Centre; 🇮🇳 2nd, India

Christian Medical College & Hospital; 🇮🇳 India

Coimbatore Chest Clinic; 🇮🇳 Road,R.S., India

Dr. D.Y. Patil Medical College; 🇮🇳 Tukaram, India

Gandhi Medical College; 🇮🇳 India

John's Medical College & Hospital; 🇮🇳 Sarajpur, Road,, India

King Edward Memorial Hospital; 🇮🇳 India

Manipal Hospital; 🇮🇳 Rustombaugh,Airport, India

Maulana Azad Medical College & Associates L.N.; 🇮🇳 Zafar, India

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Asthma Allergy Centre

🇮🇳Colony, India

Dr. Pramod Niphadkar

Principal investigator

022-24135718

site176CRC@ncr-india.com