Clinical trial NCT01964885: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Common Cold
Upper Respiratory Tract Infections
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Difference in severity of common cold symptoms for cold episodes between the two arms
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of cold episodes
timeFrame: 12 weeks
measure: Duration of cold episodes
timeFrame: 12 weeks
measure: Severity of cold symptoms over the first 4 days of the episode
timeFrame: 12 weeks
measure: Severity of cold symptoms over the first 7 days of the episode
timeFrame: 12 weeks
measure: Day and score value of the maximal WURSS-21 daily score
timeFrame: 12 weeks
measure: Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter
timeFrame: 12 weeks
measure: Incidence of viral infection
timeFrame: 12 weeks
measure: Use of rescue medication
timeFrame: 12 weeks
measure: Number of days on sick leave related to cold episodes
timeFrame: 12 weeks
measure: Number of re-infections
timeFrame: 12 weeks
measure: Severity of cold symptoms at first episode
timeFrame: 12 weeks
measure: Severity of cold symptoms at recurring (subsequent) episodes
timeFrame: 12 weeks
measure: Severity of cold episodes during the 4 week follow-up period
timeFrame: 12 weeks
measure: Changes in special laboratory parameters in the subgroup
timeFrame: 7 days
measure: Changes in cytokine production in the subgroup
timeFrame: 7 days
measure: global evaluation of the benefit by the subjects / investigators
timeFrame: 12 weeks
measure: Global assessment of tolerability by subjects/investigators
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Udo Bongartz
Study officials:
name: Udo Bongartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: