A study to evaluate the efficacy and safety of 2 study drugs in treatment of patients with allergic rhinitis

Phase 4

Completed

• Conditions: Male and female subjects of 18 years and above with allergic rhinitis

• Registration Number: CTRI/2012/08/002941
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

It is an  randomized, open label, prospective, two arm, comparative multicentric study to evaluate the efficacy and safety of montelukast and fexofenadine fixed dose combination vs montelukast and levocetirizine fixed dose combination in the management of patients with allergic rhinitis.

**Primary Endpointsxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /**

- The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS)] at the end of study as compared to baseline.

**Secondary Endpoints**

- Total nasal symptom score (TNSS) *(**nasal congestion, rhinorrhea, nasal itching, and sneezing)* at the end of study as compared to baseline

- Total Ocular symptom score (TOSS) *(Itching/burning eyes, tearing/watering eyes and eye redness)* at the end of study as compared to baseline

- Physician’s and Patient’s Global assessment for efficacy and tolerability

- To evaluate the safety by assessing the type, number, frequency and proportion of patients with Adverse Event(s) during the study.

Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS) will be graded on 4-point categoric scale:

*0 = none/ no symptoms;*

*1 = mild symptoms, but not affecting any activities during the day/sleep at night;*

*2 = moderate symptoms affecting at least one activity or disturbing sleep;*

*3 = severe symptoms affecting >2 daily activities or disturbing sleep all night or most of the night*

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-06
• Last Update Posted: 2012-11-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1.Males and females patients more than 18 years of age.
• 2.Patients with diagnosis of Allergic Rhinitis (patients with a total nasal symptom score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a total ocular symptom score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater.) 3.Except Allergic Rhinitis, patients must be in general good health based on screening.
• 4.Patients having bronchial symptoms along with Allergic Rhinitis are also allowed to participate in the study.
• 5.Patients must give written informed consent after reading the Patient Information sheet and Informed Consent Form and having had the opportunity to discuss the study with the Investigator.
• 6.Patient willing to follow up and comply with the Protocol requirements.

Exclusion Criteria

• 1.Males and females patients less than 18 years of age.
• 2.Pregnant and lactating women patients.
• 3.Patients not willing to comply with the study protocol and provide written informed consent to participate.
• 4.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
• 5.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder.
• 6.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives.
• 7.Expected use of any other medications for allergic rhinitis or conjunctivitis during the treatment period e.g. antihistamines, corticosteroids (inhaled, oral, parenteral, nasal and ophthalmic), cromolyn sodium, nedocromil and inhaled cholinergics.
• 8.Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted.
• 9.No allergic rhinitis rescue medications are permitted during the study.
• 10.Patient not willing to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS)] at the end of study as compared to baseline	baseline, Day 7 and Day 14

Secondary Outcome Measures

Name	Time	Method
•Total nasal symptom score (TNSS) (nasal congestion, rhinorrhea, nasal itching, and sneezing) at the end of study as compared to baseline	Baseline, Day 7 and Day 14

Trial Locations

Locations (4)

Gowri Prasana Diabetes & Heart Care Centre; 🇮🇳 Bangalore, KARNATAKA, India

Grant Government Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

Pace Clinical Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Public Health Centre; 🇮🇳 Chennai, TAMIL NADU, India

Gowri Prasana Diabetes & Heart Care Centre

🇮🇳Bangalore, KARNATAKA, India

DrCVSrinivas

Principal investigator

080-25459599

game_sri@yahoo.com