Benefit and Tolerability of IQP-AS-105 in Reducing Suscep... | NCT01964885

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

NCT01964885

Sponsor

InQpharm Group

Status

Terminated

Last Update Posted

Feb 12, 2016Estimated

Enrollment

140Actual

Phase

Phase 3

Conditions

Common Cold
Upper Respiratory Tract Infections

Interventions

IQP-AS-105
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No significant results during interim analysis

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Apr 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 15, 2013

First Submission Date that Met QC Criteria

Oct 15, 2013

First Posted Date

Oct 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2016

Last Update Posted Date

Feb 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IQP-AS-105	Active Comparator	One tablet daily	Dietary Supplement: IQP-AS-105
Placebo	Placebo Comparator	One tablet daily	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IQP-AS-105	Dietary Supplement		IQP-AS-105
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

ID	Term
D003139	Common Cold
D012141	Respiratory Tract Infections