Home spray inhalation in High risk asthma

Health related cross-sectional drug utilization surveillance case control study on Home Nebulization in Bronchial asthma (HRAA study) - HRAA study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/11/016319

Enrollment

Registered

2018-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: J455- Severe persistent asthma

Interventions

Intervention1: Formoterol/ Budesonide, xanthines, glycopyrolate: Route of administartion: nebulization, with Duration of Treatment as 12 wks Control Intervention1: budesonide with xanthines: Route of

Eligibility

Inclusion criteria

Inclusion criteria: Adults with Moderate to Severe Br. asthma ie. poorly controlled receiving low or med-dose ICS/LABA with history of Oral Steroid use or Hospitalization or Frequent use of rescue medications for exacerbations

Exclusion criteria

Exclusion criteria: Patients with Smoking or Non-smoking Risk factors including exposure to Biomass or Occupational hazard exposure Patients on LTRAs &/or antihistamine combinations

Design outcomes

Secondary

Measure	Time frame
TEAE (2 %) at 12 wksTimepoint: 12 weeks	—

Primary

Measure	Time frame
a. FEVl improvement at 8 wks b. PEFR improvement at 4 & 8 wks c. Change in GINA assessment score at 4 and 8 wks d. TEAE (2 %) at 12 wksTimepoint: 4 weeks 8 weeks	—

Countries

India

Contacts

Public ContactDr K Krishnaprasad

Glenmark Pharmaceuticals Ltd.

K.Krishna.Prasad@glenmarkpharma.com9820806811

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026