A clinical trial to compare the evaluation of efficacy, safety and tolerability of three expectorants in the treatment of productive cough associated with acute bronchitis, AECB, pneumonia and asthmatic bronchitis in Indian population

TO COMPARE THE EVALUATION OF EFFICACY, SAFETY AND TOLERABILITY OF COMBINATION OF SALBUTAMOL 2 mg + BROMHEXINE HCI 8 mg + GUAIFENESIN 100 mg (ASCORIL EXPECTORANT VS SALBUTAMOL 2 mg + GUAIFENESIN 100 mg EXPECTORANT VS SALBUTAMOL 2 mg + BROMHEXINE HCI 8 mg IN THE TREATMENT OF PRODUCTIVE COUGH ASSSOCIATED WITH ACUTE BRONCHITIS, AECB, PNEUMONIA AND ASTHMATIC BRONCHITIS IN INDIAN POPULATION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000112

Enrollment

354

Registered

2009-03-25

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

None listed

Interventions

Intervention1: Expectorant combination of Salbutamol 2mg + Bromhexine HCl 8 mg + Guaifenesin 100 mg: 5ml three times a day for 7 days Control Intervention1: Salbutamol 2 mg + Guaifenesin 100 mg expect

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex 18-65 years 2. Subjects giving written informed consent 3. Patients with Productive Cough associated with Acute Bronchitis, AECB, Pneumonia and Asthmatic Bronchitis 4. In the opinion of the investigator, able to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with Cystic Fibrosis 2. Patients with Active Tuberculosis 3. Patients with lung cancer or lung metastasis 4. Patients with severe bronchiectasis 5. Patients with acute respiratory decompensation 6. Patients with Chronic respiratory insufficiency associated with resting hypoxemia, 7. Patients requiring hospitalization for parenteral antibiotic treatment 8. Patients with hypersensitivity against the medication under study 9. Patients with Female patients with child bearing potential- Who are pregnant Who are breastfeeding Who are not practicing acceptable methods of birth control

Design outcomes

Primary

Measure	Time frame
To compare the change in consistency of sputum between the test and reference drugsTimepoint: End of study	—

Secondary

Measure	Time frame
To compare the change in volume of sputum, frequency and severity of cough, breathlessness from baseline and between the groups.Timepoint: End of study	—

Countries

India

Contacts

Public ContactDr. Akhilesh Sharma

Medical Services

akhileshs@glenmarkpharma.com91-22-40189999

Outcome results