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

Perennial Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228630
• Other study ID #: LOREMS0810
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2010
• Last updated: April 7, 2016
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2016
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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, ß-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 Design

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

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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.
• Allegra-D
The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Locations

Country	Name	City	State
Brazil	Lal Clínica Pesquisa E Desenvolvimento Ltda	Valinhos	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	EMS S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No