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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01964885
• Other study ID #: INQ/012213
• Status: Terminated
• Phase: Phase 3
• First received: October 15, 2013
• Last updated: February 10, 2016
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Disease Susceptibility
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Dietary Supplement:
• IQP-AS-105

• Placebo

Locations

Country	Name	City	State
Germany	Udo Bongartz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in severity of common cold symptoms for cold episodes between the two arms	Assessed by WURSS-21	12 weeks	No
Secondary	Incidence of cold episodes		12 weeks	No
Secondary	Duration of cold episodes		12 weeks	No
Secondary	Severity of cold symptoms over the first 4 days of the episode		12 weeks	No
Secondary	Severity of cold symptoms over the first 7 days of the episode		12 weeks	No
Secondary	Day and score value of the maximal WURSS-21 daily score		12 weeks	No
Secondary	Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter		12 weeks	No
Secondary	Incidence of viral infection		12 weeks	No
Secondary	Use of rescue medication		12 weeks	No
Secondary	Number of days on sick leave related to cold episodes		12 weeks	No
Secondary	Number of re-infections		12 weeks	No
Secondary	Severity of cold symptoms at first episode		12 weeks	No
Secondary	Severity of cold symptoms at recurring (subsequent) episodes		12 weeks	No
Secondary	Severity of cold episodes during the 4 week follow-up period		12 weeks	No
Secondary	Changes in special laboratory parameters in the subgroup		7 days	No
Secondary	Changes in cytokine production in the subgroup		7 days	No
Secondary	global evaluation of the benefit by the subjects / investigators		12 weeks	No
Secondary	Global assessment of tolerability by subjects/investigators		12 weeks	Yes