A clinical trial to study the efficacy and safety of Montelukast and Fexofenadine fixed dose combination tablet Versus Fexofenadine tablet alone in the patients of Allergic Rhinitis.
- Conditions
- Health Condition 1: null- Allergic Rhinitis
- Registration Number
- CTRI/2010/091/001300
- Lead Sponsor
- upin Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
1.Males and females patients more than 18 years of age.
2.Written informed consent signed by patient and willing to comply with the study procedure.
3.Patients with diagnosis of Allergic Rhinitis
4.Except Allergic Rhinitis patients must be in general good health based on screening, vital, systemic examination and medical history.
5.Patients having mild asthma along with Allergic Rhinitis are also allowed to participate provided they used only inhaled, short acting beta-agonists bronchodilators to treat asthma.
6.In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test.
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.Patients with Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
5.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
6.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder.
7.Patients who had initiation of allergen immunotherapy within previous 6 months.
8.Participation in any investigational drug trial within the 90 days preceding the screening visit or planned participation in another investigational drug trial at any time during this trial.
9.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives.
10.Patients with known history of rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption will also be excluded from the trial.
11.Patients with history of hepatic impairment (alcohol related liver disease or cirrhosis), renal impairment, cardiac impairment and patients who had recently undergone a major surgical procedure or any other condition that in the judgment of the investigator not suitable to be recruited in the study.
12.The patients who are currently not on for following medications Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (3 days).
13.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. Oral or long acting beta-agonist, theophylline and leukotriene modifiers are also disallowed. Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted. No allergic rhinitis rescue medications are permitted during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Daytime nasal symptom score (i.e. the mean of four individual symptoms score: nasal congestion, rhinorrhea, nasal pruritus and sneezing) 2.Nighttime nasal symptom score (i.e. the mean of three symptoms score: difficulty going to sleep, nighttime awakenings, nasal congestion on awakenings) 3.Daily composite symptoms score (i.e. the mean of the daytime nasal symptom score and nighttime nasal symptom score). 4.Individual daytime nasal symptom score 5.Individual nighttime nasal symptom score 6.Peripheral blood Eosinophils 7.Rhinocojunctivitis Quality of Life Questionnaire (RQOL) 8.Physician?s and Patient?s Global assessment of the treatment. 14 Days [Delete] <br><br><br><br><br><br>Timepoint: 0, 7th and 14th Days
- Secondary Outcome Measures
Name Time Method 1.To evaluate the safety by assessing the type, number, frequency and proportion of patients with Adverse Event(s) during the trial phase. 2.Concomitant medication (to be taken to overcome any adverse events). <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 7th and 14th Days <br/ ><br>