Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis.

The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Cloratadd-D; Drug: Allegra-D

Detailed Description

The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Valinhos, Sao Paulo, Brazil, 13270-245
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
• Have age over 12 years, regardless of gender, ethnicity or social class;
• Present clinical status of perennial allergic rhinitis from mild to moderate;
• Present clinical status with at least 12 months of evolution;
• Submit the examination of IgE elevation (above 100KU / L).

Exclusion Criteria:

• Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
• Pregnant or lactating women;

• Have made use of:

  1. Intranasal or systemic corticosteroids in the month before inclusion;
  2. Intranasal cromolyn in the two weeks preceding inclusion;
  3. Intranasal or systemic decongestants in the 03 days preceding inclusion;
  4. Intranasal antihistamines or systemic in the 03 days preceding the survey;
  5. Loratadine in the 10 days preceding the survey.
• have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
• History of smoking in the 03 months preceding the inclusion;
• History of alcohol or illicit drugs;
• History of liver disease or kidney disease;
• Electric current asthma or gift last year;
• Table of uncontrolled hypertension;
• Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
• Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
• Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
• Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
• Estimated travel or displacement of the southeast for more than 50% of monitoring.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cloratadd-D; Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.	Drug: Cloratadd-D; The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.; Other Names: Loratadine + pseudoephedrine
Active Comparator: Allegra-D; Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.	Drug: Allegra-D; The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.; Other Names: Loratadine + pseudoephedrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs and symptoms evaluated by a PHYSICIAN	Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.	28 days of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms reported by PATIENTS	Symptoms of runny nose,nasal congestion, itchy nose, sneezing, quality of life.These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.	28 days of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: EMS S/A
• Investigators: Principal Investigator: Luiz Tikara Shimizu, PI, LAL Clínica Pesquisa e Desenvolvimento Ltda

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: rhinitis, loratadine, coated pill
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Central Nervous System Stimulants; Sympathomimetics; Histamine H1 Antagonists, Non-Sedating; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine; Loratadine; Fexofenadine
• Other Study ID Numbers: LOREMS0810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It believed that after the data analysis and presentation to the IRC, all data will become public.