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" Effects of Montelukast treatment in asthmatic children under 5 years"

" Therapeutic effect of Fluticasone and Montelukast in children younger than 5 years with recurrent wheeze"

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204099429N1
Enrollment
68
Registered
2013-09-08
Start date
2013-08-29
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

"Asthma in children". Asthma

Interventions

Intervention 1: Intervention: 5 mg montelukast daily. Intervention 2: Control: fluticasone 100 mcg spray two puffs twice a day.
Treatment - Drugs
Intervention: 5 mg montelukast daily
Control: fluticasone 100 mcg spray two puffs twice a day

Sponsors

"Tabriz University of Medical Sciences, Assistance Research"
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (no abnormalities underlying anatomic disease? family history of allergies and asthma patient ) And exclusion criteria: (anatomical issues such as the children with Gastroesophageal Reflux Disease? Cystic fibrosis ? underlying medical condition such as cardiovascular problems they are not in the study).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
"Wheeze intensity". Timepoint: The severity of wheezing diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up. Method of measurement: Physical examination.

Secondary

MeasureTime frame
"Cough intensity". Timepoint: The severity of coughing diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up. Method of measurement: Physical examination.;"Dyspnea intensity". Timepoint: The severity of dyspnea diagnosed based on clinical examination and recorded every 2-4 weeks to 6 months after starting treatment with Montelukast 5 mg daily and Fluticasone 100 mcg twice a day, patients are followed up. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact"Maryam Abbasnazhad"

"Tabriz University of Medical Science"

mabbasnazhad@yahoo.com+98 41 1336 4650

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026