Health Condition 1: - Health Condition 2: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Levocetirizine HCl IP 5mg Plus Montelukast Sodium IP equivalent to Montelukast 10 mg
and Ambroxol HCl IP 75 mg uncoated bilayer tablets: fixed dose combination of Levocetirizine HCL 5
m
Sponsors
GKM New Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing and able to sign informed consent form. 2. Male & female subjects between age group 18 years - 60 years 3. Patients with productive cough associated with established diagnosed Allergic Rhinitis who have not taken any medications for at least 2 weeks. 4. Patients who agree to maintain consistency in their surroundings throughout the study 5. Patient with no allergies to any of the ingredients of the study drug 6. Patient willing to follow the protocols requirements
Exclusion criteria
Exclusion criteria: 1. Patient hypersensitivity to Levocetirizine Hydrochloride or Montelukast or Ambroxol HCl or any excipients 2. Patient with upper respiratory tract infection or acute/chronic pulmonary disorder 3. Patient with non-allergic rhinitis with different causes. 4. Patients with severe asthma. 5. Presence of nasal polyps or any clinically important nasal anomaly 6. History of acute / chronic sinusitis within 30 days of visit 1 7. History of intranasal / eye surgeries within 3 months of Visit 1 8. Initiation of immunotherapy or dose modification within 1 month prior to Visit 1 9. Patient requiring other antihistamine, corticosteroids (oral and / parenteral), immunotherapy, cromolyn sodium, nedocromil and inhaled cholinergics, oral or long acting beta-agonist, theophylline, tricyclic antidepressants, other leukotriene modifiers and bronchodilators etc. 10. Patients on decongestants, anti- inflammatory medicines and other rescue medicines for allergic rhinitis. 11. At visit 2, patient recording Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period. 12. Patient suffering from any other psychiatric illness or any other chronic disease which would interfere with trail assessments. 13. Known contraindication for the use of Levocetirizine Hydrochloride, Montelukast and Ambroxol. 14. A history of drug or alcohol abuse within the past 6 months 15. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study. 16. Female who is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Sputum viscosity score and Expectoration Difficulty Score from baseline to end of treatmentTimepoint: Visit 2 [Baseline visit (eligibility confirmation visit) , Day 0] Visit 3 (week 2) Visit 4 (End of study visit, week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in daytime nasal symptom score from baseline to end of the treatment 2. Mean change in nighttime symptoms score from baseline to end of treatment. 3. Mean change in daytime eye symptoms score from baseline to end of treatment. 4. Global assessment for efficacy and tolerability by investigator and patient will be assessed at the end of study i.e. at Week 4. 5. Treatment emergent adverse event (TEAEs).Timepoint: Visit 1 (Screening visit, Day -7) Visit 2 [Baseline visit (eligibility confirmation visit) , Day 0] Visit 3 (week 2) Visit 4 (End of study visit, week 4) | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
iDD Research Solutions INC
Outcome results
None listed