Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms - Full Text View

Sponsored by:	Milsing d.o.o.
Information provided by:	Milsing d.o.o.
ClinicalTrials.gov Identifier:	NCT00460538

Purpose

The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Dietary Supplement: Lectranal Dietary Supplement: placebo	Phase IV

MedlinePlus related topics: Dietary Supplements Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Further study details as provided by Milsing d.o.o.:

Primary Outcome Measures:

changes in SARS (seasonal allergic rhinitis symptoms) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in specific IgE [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in specific IgG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prick test change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
change in eosinophilia in nasal secretion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	April 2007
Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator	Dietary Supplement: placebo Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks
1: Active Comparator	Dietary Supplement: Lectranal Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks

Detailed Description:

Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

history of seasonal allergic rhinitis symptoms to pollen
positive skin prick test to pollen
negative history of seasonal allergic asthma
male or female older than 18
female participants must use appropriate contraception
able to comply to study procedures

Exclusion Criteria:

pregnancy
alcohol or drug abuse
subject receiving antihistamines , immunotherapy or on hyposensibilisation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460538

Locations

Croatia
Dubrava University Hospital
Zagreb, Croatia, 10000

Sponsors and Collaborators

Milsing d.o.o.

Investigators

Principal Investigator:

Neven Tudoric, MD PhD

Dubrava University Hospital

More Information

Responsible Party:	Dubrava University Hospital, Zagreb, Croatia ( Neven Tudoric MD PhD )
Study ID Numbers:	MIL-002
Study First Received:	April 13, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00460538
Health Authority:	Republic of Croatia: Ethic Committee of Dubrava University Hospital

Keywords provided by Milsing d.o.o.:

Seasonal allergic rhinitis
lectranal
allergy

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009