Short-term and longterm growth in children with asthma treated with budesonide or montelukast

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003013-41-DK

Enrollment

Registered

2006-06-29

Start date

2006-07-13

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

asthma

Interventions

Trade Name: Pulairmax Product Name: Pulairmax Pharmaceutical Form: Inhalation powder INN or Proposed INN: Budesonide drypowder Concentration unit: µg microgram(s) Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 6-11 prepubertal asthma normal weight and height informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: concurrent treatment with glucocorticoids (other than investigational product) major surgery within 4 weeks

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess if treatmant with budesonide 200 micrograms per day affect short-term or long-term growth in children with asthma;Secondary Objective: To assess if compliance can be evaluated by measuring exhaled NO To assess if asthma disease severity can be evaluated by inflammatory markers in the urine ;Primary end point(s): short-term growth long-term growth (1 year)	—

Countries

Denmark

Outcome results

None listed

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