A clinical trial to study the effect of cough mixture syrup of levosalbutamol, ambroxol and guaiphenesin in the treatment of patients suffering from productive cough associated with acute bronchitis.

Phase 3

• Conditions: Productive Cough Associated with Acute Bronchitis

• Registration Number: CTRI/2012/03/002477
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is double-blind, randomized, placebo controlled, two-arm, parallel-group, comparative study. The study will be conducted in patients suffering from productive cough associated with acute bronchitis. Study will enroll 260 patients across different centers from India.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting all inclusion/exclusion criteria) in 1:1 ratio to receive either mixture of Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin syrup or placebo syrup for eight days.

The primary objective of the study is to see the ease of cough and clearance of sputum. Secondary objective includes improvement in breathlessness, reduction in sputum volume, decrease in consistency of sputum, change in mean bronchial severity score, change in patient’s general well being and safety evaluation.

During the study, there will be 3 study visits at day 0, day 3 and day 8 for efficacy, safety and tolerability assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• 1.Male or female ≥18 to <60 years and willing to give their written informed consent.
• 2.Patients with a recent onset of < or equal to 2 days of bronchial mucus production with impaired ability to cough up, and a baseline Bronchial Severity Score (BSS) of ≥5 score points out of a maximum of 20 points 3.Patients willing to comply with the protocol requirements.

Exclusion Criteria

• 1.Pregnant or lactating women.
• 2.Patient with known hypersensitivity to any of the components of the formulation.
• 3.Female patients of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
• 4.Patient with alcohol or drug dependence.
• 5.Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease.
• 6.Patients with antibiotic use in the preceding 2 weeks 7.Patients with a concurrent infection including Tuberculosis (TB) requiring antibiotic treatment.
• 8.Patients with malignant growth or any severe somatopathic, neurologic and / or psychiatric disease.
• 9.Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator 10.Patients who have participated in any clinical trial in the past 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ease of Cough and Clearance of Sputum	8-days

Secondary Outcome Measures

Name	Time	Method
1.Improvement in Breathlessness	8-days
2.Reduction in Sputum Volume	8-days
3.Decrease in Consistency of Sputum	8-days
4.Change in mean Bronchial Severity Score	8-days
5.Change in Patient’s General Well being	8-days

Trial Locations

Locations (11)

Dayal Clinic; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

M. S. Diabetes & Shirdi Skin Care Center; 🇮🇳 Bangalore, KARNATAKA, India

Medimart Clinic & Pharmacy; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Pt. J. N. M Medical College; 🇮🇳 Raipur, CHHATTISGARH, India

RC ENT Clinic; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Sai Chatanya Clinic; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Sapthagiri Institute of Medical Science; 🇮🇳 Bangalore, KARNATAKA, India

Seventh Day Adventist Medical Center; 🇮🇳 Bangalore, KARNATAKA, India

Sri Clinic; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Dayal Clinic

🇮🇳Visakhapatnam, ANDHRA PRADESH, India

Dr S Sreenivas

Principal investigator

08912745490

s.sreenivaas3@gmail.com