CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM

?A CONTROLED LABELED, DOUBLE ARM, RANDOMIZED, MULTI- CENTRIC, PROSPECTIVE PHASE III CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM OF DIFFERENT ETIOLOGY?

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001041

Enrollment

150

Registered

2010-02-15

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: null- patient suffering with Acute BRONCHOSPASM OF DIFFERENT ETIOLOGY

Interventions

Intervention1: DOXOPHYLLINIntervention: IMP FDC OF DOXOFYLLINE 800mg SR AND MONTELUKAST 10mg: 800MG,100MG(10 DAYS) Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex of age >= 18 and Patient suffering from mild to moderate bronchospasm of different etiology. PEF between 50% to 80 % (mild to moderate)by using Peak flow meter. Pre menopausal women must use the appropriate contraception. Patient willing to give informed consent.

Exclusion criteria

Exclusion criteria: Patients with significant pulmonary insufficiency, including both intrinsic lung disease and Respiratory failure i.e. severe bronchospasm Patient with a history of known hypersensitivity from any one of the said medication. Patients with acute myocardial infarction, hypotension. Patients with uncontrolled hypertension. Bronchospasm of anaphylactic, mechanical or cancerous origin. Subjects with severe hepatic, renal failure or encephalopathy. Chronic alcoholics. Patients with history of cardiac surgery. Pregnant & lactating women.

Design outcomes

Primary

Measure	Time frame
To compare efficacy of the FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR in subjects suffering with acute bronchospasm of different etiology.Timepoint: 10 DAYS	—

Secondary

Measure	Time frame
To compare the safety & tolerability of FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR on oral administration in subjects suffering with acute bronchospasm of different etiology Timepoint: 10 DAYS	—

Countries

India

Contacts

Public Contactmr shunmugam

CRA

sameena.k@nexuscro.com09891783557

Outcome results

None listed

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