Muscarinic and leukotrine antagonist in childhood asthma

Inhaled Corticosteroids plus Tiotropium compared to Inhaled Corticosteroids plus Montelukast in Children with Persistent Asthma Symptoms: A Non-Inferiority Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045331

Enrollment

152

Registered

2022-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

Intervention1: ICS plus Tiotropium (9 µg) OD by metered dose inhaler (MDI) with VHC (volume holding chamber): ICS plus Montelukast tablet 5 mg once daily (OD) in the evening Intervention2: Tiotropium

Eligibility

Inclusion criteria

Inclusion criteria: persistent asthma symptoms (step 2 and step 3) despite ICS as per GINA 2021 guideline

Exclusion criteria

Exclusion criteria: (1) History of known hypersensitivity or contraindication to anti-cholinergic drugs (2) Children with neuropsychiatry problems (3) Use of oral steroid in past 6 weeks

Design outcomes

Primary

Measure	Time frame
Proportion of children with achievement of asthma control as assessed by C-ACTTimepoint: at the end of 3 months	—

Secondary

Measure	Time frame
Adverse eventsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Asthma control as assessed by c-ACT scoreTimepoint: from baseline to the end of 12 (3 months) & 24 weeks (6 months);Cost-effectivenessTimepoint: 24 weeks (6 months);Improvement in FeV1Timepoint: 24 weeks (6 MONTHS) of treatment;Number of exacerbation as assessed by emergency department visits and use of reliever/rescue medication, oral steroidsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Quality of life Timepoint: 12 weeks (3 months) and 24 weeks (6 months)	—

Measure

Time frame

Adverse eventsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Asthma control as assessed by c-ACT scoreTimepoint: from baseline to the end of 12 (3 months) & 24 weeks (6 months);Cost-effectivenessTimepoint: 24 weeks (6 months);Improvement in FeV1Timepoint: 24 weeks (6 MONTHS) of treatment;Number of exacerbation as assessed by emergency department visits and use of reliever/rescue medication, oral steroidsTimepoint: 12 weeks (3 months) and 24 weeks (6 months);Quality of life Timepoint: 12 weeks (3 months) and 24 weeks (6 months)

—

Countries

India

Contacts

Public ContactSoma Sengupta

All India Institute of Medical Sciences (AIIMS)

rrdas05@gmail.com9438884188

Outcome results

None listed

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