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

This study has been completed.
Sponsor:
Collaborator:
EMS S/A
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01228630
First received: October 18, 2010
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Cloratadd-D
Drug: Allegra-D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Signs and symptoms evaluated by a PHYSICIAN [ Time Frame: 28 days of treatment. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Symptoms reported by PATIENTS [ Time Frame: 28 days of treatment. ] [ Designated as safety issue: No ]
    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.


Enrollment: 156
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Loratadine + pseudoephedrine

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.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228630

Locations
Brazil
Lal Clínica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270-245
Sponsors and Collaborators
Azidus Brasil
EMS S/A
Investigators
Principal Investigator: Luiz Tikara Shimizu, PI LAL Clinica Pesquisa e Desenvolvimento Ltda
  More Information

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01228630     History of Changes
Other Study ID Numbers: LOREMS0810 
Study First Received: October 18, 2010
Last Updated: April 7, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: It believed that after the data analysis and presentation to the IRC, all data will become public.

Keywords provided by Azidus Brasil:
rhinitis, loratadine, coated pill

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Fexofenadine
Ephedrine
Pseudoephedrine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 28, 2016