Clinical Trials Logo
  1. Home
  2. Rhinitis
  3. NCT00525278
  4. Details
NCT00525278 Clinical Trial

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Rhinitis Clinical Trial

Official title:
Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00525278
Other study ID # A00348
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2007
Last updated December 13, 2013
Start date August 2003
Est. completion date October 2003

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority China: Department of Health, Pharmaceuticals registration and Import/Export control section
Study type Interventional

Clinical Trial Summary

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date October 2003
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Male or female, 18 to 60 years old, inclusive

- two-year history of allergic rhinitis due to tree, grass or weed pollen

- sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS = 5)

Exclusion Criteria:

- An ear, nose or throat (ENT) infection

- asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn

- atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment

- an associated ENT disease

- use of decongestants

- nasal or ocular topical treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levocetirizine dihydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator rated T5SS (Total 5 symptom Score) over 2 weeks 2 weeks
Secondary Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI). 2 weeks
See also
  Status Clinical Trial Phase
Completed NCT02360072 - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed NCT02340130 - Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma Phase 2
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00762567 - Phenylephrine Pediatric Pharmacokinetic Study Phase 1
Completed NCT00541255 - A Long-Term Examination of Asthma From Childhood Through Adolescence
Completed NCT00279916 - Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays Phase 3
Completed NCT00963573 - Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428) Phase 4
Completed NCT00524836 - Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis Phase 3
Completed NCT00521131 - Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites Phase 4
Completed NCT04132570 - A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution Phase 4
Completed NCT02784262 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis Phase 2
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02279706 - Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test N/A
Completed NCT01971086 - Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary N/A
Completed NCT01771120 - Control and Burden of Asthma and Rhinitis N/A
Withdrawn NCT01177852 - Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis Phase 3
Completed NCT01469234 - A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) Phase 4
Completed NCT00724698 - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Completed NCT02879929 - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction N/A

External Links