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

Primary Purpose

Common Cold, Upper Respiratory Tract Infections

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
IQP-AS-105
Placebo
Sponsored by
InQpharm Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Cold

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Udo Bongartz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IQP-AS-105

Placebo

Arm Description

One tablet daily

One tablet daily

Outcomes

Primary Outcome Measures

Difference in severity of common cold symptoms for cold episodes between the two arms
Assessed by WURSS-21

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2013
Last Updated
February 10, 2016
Sponsor
InQpharm Group
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1. Study Identification

Unique Protocol Identification Number
NCT01964885
Brief Title
Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections
Official Title
Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
No significant results during interim analysis
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Upper Respiratory Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IQP-AS-105
Arm Type
Active Comparator
Arm Description
One tablet daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet daily
Intervention Type
Dietary Supplement
Intervention Name(s)
IQP-AS-105
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference in severity of common cold symptoms for cold episodes between the two arms
Description
Assessed by WURSS-21
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of cold episodes
Time Frame
12 weeks
Title
Duration of cold episodes
Time Frame
12 weeks
Title
Severity of cold symptoms over the first 4 days of the episode
Time Frame
12 weeks
Title
Severity of cold symptoms over the first 7 days of the episode
Time Frame
12 weeks
Title
Day and score value of the maximal WURSS-21 daily score
Time Frame
12 weeks
Title
Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter
Time Frame
12 weeks
Title
Incidence of viral infection
Time Frame
12 weeks
Title
Use of rescue medication
Time Frame
12 weeks
Title
Number of days on sick leave related to cold episodes
Time Frame
12 weeks
Title
Number of re-infections
Time Frame
12 weeks
Title
Severity of cold symptoms at first episode
Time Frame
12 weeks
Title
Severity of cold symptoms at recurring (subsequent) episodes
Time Frame
12 weeks
Title
Severity of cold episodes during the 4 week follow-up period
Time Frame
12 weeks
Title
Changes in special laboratory parameters in the subgroup
Time Frame
7 days
Title
Changes in cytokine production in the subgroup
Time Frame
7 days
Title
global evaluation of the benefit by the subjects / investigators
Time Frame
12 weeks
Title
Global assessment of tolerability by subjects/investigators
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udo Bongartz, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Udo Bongartz
City
Berlin
ZIP/Postal Code
10369
Country
Germany

12. IPD Sharing Statement

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

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