Common ColdPhase 3NCT01964885
Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections
A Phase 3 study testing IQP-AS-105 in people with Common Cold and Upper Respiratory Tract Infections, run by InQpharm Group at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Upper Respiratory Tract Infections
- What is being tested?
- IQP-AS-105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections
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
- Being tested
- IQP-AS-105, Placebo
- Medical subject headings
- Common Cold, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-AS-105Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| IQP-AS-105 | Active comparator | One tablet daily Receives: Dietary Supplement: IQP-AS-105 |
| Placebo | Placebo comparator | One tablet daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in severity of common cold symptoms for cold episodes between the two arms
Assessed by WURSS-21
Measured: 12 weeks
Secondary outcomes (17)
Incidence of cold episodes
Measured: 12 weeks
Duration of cold episodes
Measured: 12 weeks
Severity of cold symptoms over the first 4 days of the episode
Measured: 12 weeks
Severity of cold symptoms over the first 7 days of the episode
Measured: 12 weeks
Day and score value of the maximal WURSS-21 daily score
Measured: 12 weeks
Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter
Measured: 12 weeks
Incidence of viral infection
Measured: 12 weeks
Use of rescue medication
Measured: 12 weeks
Number of days on sick leave related to cold episodes
Measured: 12 weeks
Number of re-infections
Measured: 12 weeks
Severity of cold symptoms at first episode
Measured: 12 weeks
Severity of cold symptoms at recurring (subsequent) episodes
Measured: 12 weeks
Severity of cold episodes during the 4 week follow-up period
Measured: 12 weeks
Changes in special laboratory parameters in the subgroup
Measured: 7 days
Changes in cytokine production in the subgroup
Measured: 7 days
global evaluation of the benefit by the subjects / investigators
Measured: 12 weeks
Global assessment of tolerability by subjects/investigators
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionMay 2014
Why it stopped: No significant results during interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udo Bongartz, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964885
- Sponsor's protocol ID
- INQ/012213
- Status last verified
- Feb 2016
- First submitted
- 15 Oct 2013
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT01964885
- Acronym / sponsor ID
- INQ/012213
- Conditions
- Common Cold, Upper Respiratory Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No significant results during interim analysis
- Enrolment
- 140 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQP-AS-105 | Active comparator | Dietary Supplement: IQP-AS-105One tablet daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne tablet daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQP-AS-105 | Dietary supplement | IQP-AS-105 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Difference in severity of common cold symptoms for cold episodes between the two arms
Time frame: 12 weeks
Assessed by WURSS-21
17 secondary outcomes
Incidence of cold episodes
Time frame: 12 weeks
Duration of cold episodes
Time frame: 12 weeks
Severity of cold symptoms over the first 4 days of the episode
Time frame: 12 weeks
Severity of cold symptoms over the first 7 days of the episode
Time frame: 12 weeks
Day and score value of the maximal WURSS-21 daily score
Time frame: 12 weeks
Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter
Time frame: 12 weeks
Incidence of viral infection
Time frame: 12 weeks
Use of rescue medication
Time frame: 12 weeks
Number of days on sick leave related to cold episodes
Time frame: 12 weeks
Number of re-infections
Time frame: 12 weeks
Severity of cold symptoms at first episode
Time frame: 12 weeks
Severity of cold symptoms at recurring (subsequent) episodes
Time frame: 12 weeks
Severity of cold episodes during the 4 week follow-up period
Time frame: 12 weeks
Changes in special laboratory parameters in the subgroup
Time frame: 7 days
Changes in cytokine production in the subgroup
Time frame: 7 days
global evaluation of the benefit by the subjects / investigators
Time frame: 12 weeks
Global assessment of tolerability by subjects/investigators
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: No significant results during interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Bongartz, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IQP-AS-105 in people with Common Cold and Upper Respiratory Tract Infections, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No significant results during interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in severity of common cold symptoms for cold episodes between the two arms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.