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Effects of newer injectable medication (biological agents) on respiratory function, exercise capacity and sleep quality in patients with bad uncontrolled asthma

Effects of biological therapy on lung function, exercise capacity and sleep quality in patients with severe asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046458
Enrollment
15
Registered
2022-10-13
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

Sponsors

Dr Randeep Guleria
Lead Sponsor
Dr Anant Mohan
Collaborator
Dr Saurabh Mittal
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with physician-diagnosed severe asthma 2. Age > 18 yrs 3. Planned to receive Benralizumab therapy 4. Patients ready to give consent

Exclusion criteria

Exclusion criteria: Not giving written informed consent

Design outcomes

Primary

MeasureTime frame
To assess the effect of benralizumab therapy on ACT score at 6 months of therapyTimepoint: To assess the effect of benralizumab therapy on ACT score at 6 months of therapy

Secondary

MeasureTime frame
ï?® To assess the effect of benralizumab therapy on AQLQ, SGRQ and HADS at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on AHI during sleep study at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on air-trapping as assessed by CT chest at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on AQLQ score at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on inflammatory markers (LDH, Ferritin) at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on lung function (pre BD FEV1, RV, TLC and RV/TLC) at 6 months of therapyTimepoint: 6 months;To assess the effect of benralizumab therapy on Sleep related quality of life at 6 months of therapyTimepoint: 6 months

Countries

India

Contacts

Public ContactSaurabh Mittal

AIIMS, New Delhi

saurabh_kgmu@yahoo.co.in9999144116

Outcome results

None listed

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