Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

This study has been completed.
Sponsor:
Information provided by:
Milsing d.o.o.
ClinicalTrials.gov Identifier:
NCT00460538
First received: April 13, 2007
Last updated: April 2, 2010
Last verified: March 2010
  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 4

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: Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Resource links provided by NLM:


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

Dosage form: capsule

1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks

Other Name: Lectranal

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
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: 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

Publications:
Responsible Party: Neven Tudoric MD PhD, Dubrava University Hospital, Zagreb, Croatia
ClinicalTrials.gov Identifier: NCT00460538     History of Changes
Other Study ID Numbers: MIL-002
Study First Received: April 13, 2007
Last Updated: April 2, 2010
Health Authority: Republic of Croatia: Ethic Committee of Dubrava University Hospital

Keywords provided by Milsing d.o.o.:
Seasonal allergic rhinitis
lectranal
allergy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 27, 2014