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

NCT01964885 | Terminated Phase 3

• 1 other identifier: INQ/012213
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Common Cold; Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Difference in severity of common cold symptoms for cold episodes between the two arms

  Assessed by WURSS-21

  12 weeks

Secondary Outcomes (17)

• 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

Study Arms (2)

IQP-AS-105

ACTIVE COMPARATOR

One tablet daily

Dietary Supplement: IQP-AS-105

Placebo

PLACEBO COMPARATOR

One tablet daily

Dietary Supplement: Placebo

Interventions

IQP-AS-105 DIETARY_SUPPLEMENT

IQP-AS-105

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Udo Bongartz

Berlin, State of Berlin, 10369, Germany

Location

MeSH Terms

Conditions

Common Cold; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Udo Bongartz, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

DE (1)