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A clinical study to evaluate the effectiveness and safety of a cough clearing formulation in comparison with ambroxol for clearing cough in bronchial asthma.

A cross-section, observational, drug utilization study to assess productive cough symptom control in Br. asthma and phenotypes (ASTHMA*Cough study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018694
Enrollment
110
Registered
2019-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J45- Asthma

Interventions

Intervention1: Terbutaline, Bromhexine, Guaiphenesin, Menthol : Route of administration: Oral with treatment duration of 7 days Control Intervention1: Ambroxol: Route of administration: Oral with tre

Sponsors

Glenmark Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults with bronchospastic respiratory conditions or bronchial asthma requiring outpatient therapy with bronchodilatory or mucolytic cough formulations.

Exclusion criteria

Exclusion criteria: Patients with Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of >=6 dosages in a day for the last week Patients who have been hospitalized and received antimicrobial therapy within the last 24 hours Patients at high risk for infection with 6Ps; pneumonia, pulmonary embolism, pneumothorax, pleural effusion, pulmonary oedema [heart failure] and paroxysmal atrial tachycardia(arrhythmias)

Design outcomes

Primary

MeasureTime frame
Cough Severity at day 7 Sputum consistency at day 7 Nocturnal awakening frequency (No. of Episodes/night) at day 7Timepoint: Day 7

Secondary

MeasureTime frame
Treatment emergent adverse event rate with Bronchodilator based Cough Formulation and ambroxolTimepoint: Day 7

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 4, 2026