Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections

Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections

IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive medicine, based on its ability to enhance the immune system responses

Study Overview

• Status: Terminated
• Conditions: Common Cold; Upper Respiratory Tract Infections
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: IQP-AS-105

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Udo Bongartz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18-70 years
• increased risk for infections - at least 4 cold episodes within 12 months
• commitment to adhere to their accustomed diet and physical activity
• women of child-bearing potential have to agree to use appropriate birth control methods
• written consent of the subject to participate is a prerequisite for study participation

Exclusion Criteria:

• acute / chronic upper airways disease
• chronic cough of any origin
• acute / chronic lower airways disease
• any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
• history of nasal reconstructive surgery
• presence of nasal ulcers or nasal polyps
• severe nasal septum deviation or other condition that could cause nasal obstruction
• congenital or acquired immunodeficiency disease (e.g. HIV infection)
• severe organ or systemic diseases
• body temperature above 37.5°C
• suspected swine flu or influenza
• vaccination against influenza or swine flu within 3 months prior to study start
• stomach/gastrointestinal diseases
• sleep disorder
• psychiatric disorders
• known sensitivity to the ingredients of the investigational product
• intake of products that may influence the study outcome within the last 14 days prior to study start and during the study
• analgesics , antibiotics or decongestant nose drops/spray, unless they are used as rescue medications
• pregnancy or nursing
• alcohol / drug abuse
• simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
• insufficient compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IQP-AS-105; One tablet daily	Dietary supplement: IQP-AS-105
PLACEBO_COMPARATOR: Placebo; One tablet daily	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in severity of common cold symptoms for cold episodes between the two arms	Assessed by WURSS-21	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of cold episodes	12 weeks
Duration of cold episodes	12 weeks
Severity of cold symptoms over the first 4 days of the episode	12 weeks
Severity of cold symptoms over the first 7 days of the episode	12 weeks
Day and score value of the maximal WURSS-21 daily score	12 weeks
Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter	12 weeks
Incidence of viral infection	12 weeks
Use of rescue medication	12 weeks
Number of days on sick leave related to cold episodes	12 weeks
Number of re-infections	12 weeks
Severity of cold symptoms at first episode	12 weeks
Severity of cold symptoms at recurring (subsequent) episodes	12 weeks
Severity of cold episodes during the 4 week follow-up period	12 weeks
Changes in special laboratory parameters in the subgroup	7 days
Changes in cytokine production in the subgroup	7 days
global evaluation of the benefit by the subjects / investigators	12 weeks
Global assessment of tolerability by subjects/investigators	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Udo Bongartz, PhD

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (ESTIMATE): October 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: INQ/012213