Respiratory Tract InfectionPhase 3NCT00240461
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
A Phase 3 study testing COLD-fX natural health product and COLD-fX in people with Respiratory Tract Infection, run by Capital Health, Canada at 5 sites in 2 countries.
Trial summary
Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infection
- What is being tested?
- COLD-fX natural health product and COLD-fX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2005to Dec 2008
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years of age and older
- current season influenza immunization
- available for follow-up visits
- willing and able to sign written informed consent
Who cannot join
- HIV infection
- malignancy (under active observation or treatment)
- unstable cardiovascular diseases
- renal abnormalities (serum creatine >200umol/l)
- pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory illness)
- acute or active chronic liver disease
Show all 18Show fewer
- neurologic or psychiatric disease (progressive or currently under treatment
- active tuberculosis
- multiple sclerosis
- bleeding disorders
- planned surgery over the course of the trial
- on immunosuppressive therapy
- taking oral steroids at dose = to prednisone 10 mg/day or more
- taking phenelzine, pentobarbital, haloperidol, warfarin, heparin
- use of natural health products(except the study product and vitamins and minerals with a dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets)
- current alcohol/drug abuse
- major surgery in the past 6 months
- allergies to ginseng
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada4 sites
Alberta Health Services
Edmonton, Alberta, T5M 3Z7
IWK Health Centre
Halifax, Nova Scotia
Sunnybrook Health Sciences Centre
Toronto, Ontario
UBC Gerontology and Diabetes Research
Vancouver, British Columbia
About this study
Official title: Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial
Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.
Read the detailed description
Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.
- Conditions
- Respiratory Tract Infection
- Being tested
- COLD-fX natural health product, COLD-fX, Placebo
- Keywords
- respiratory, infection, influenza
- Medical subject headings
- Respiratory Tract Infections, Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLD-fX natural health productDietary supplement
Also called Natural health product, dietary supplement
200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
COLD-fXDietary supplement
Also called naural health products, dietary supplements
400 mg COLD-fX natural health product 2 times daily for 6 months
PlaceboOther
Also called none available
crystalline substance 200 mg twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 200 mg COLD-fX Natural health products 2 times daily for six months Receives: Dietary Supplement: COLD-fX natural health product |
| Arm 2 | Active comparator | Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months Receives: Dietary Supplement: COLD-fX |
| 3 | Placebo comparator | Inactive crystalline substance. This is the placebo arm in which subject receive 200 mg of the placebo 2 times daily for 6 months. Placebo is an inactive crystalline substance. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
Measured: During the study time frame of 6 months
Secondary outcomes (1)
To evaluate the effects of the treatment on the incidence and frequency of all respiratory infections meeting the Jackson criteria and to determine the efficacy of COLD-fX supplementation on the severity and duration of symptoms.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Health, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Afexa Life Sciences Inc, IWK Health Centre, Sunnybrook Health Sciences Centre, Erasmus Medical Center, University of BC Gerontology & Diabetes Research
- Investigators
- Gerry Predy, MD, Principal investigator, Capital Health, CanadaShelly McNeil MD, Principal investigator, IWK Health CentreJan McElhaney, Principal investigator, UBC Gerontology and Diabetes ResearchAndrew Simor MD, Principal investigator, Sunnybrook Health Sciences CentreAlbert Osterhaus Dr., Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240461
- Sponsor's protocol ID
- CVT-E002-2005-2
- Status last verified
- Jul 2011
- First submitted
- 14 Oct 2005
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00240461
- Acronym / sponsor ID
- CVT-E002-2005-2
- Conditions
- Respiratory Tract Infection
- Keywords
- respiratory, infection, influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Capital Health, CanadaUniversity, hospital or other
- Collaborators
- Afexa Life Sciences Inc, IWK Health Centre, Sunnybrook Health Sciences Centre, Erasmus Medical Center, University of BC Gerontology & Diabetes Research
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Oct 2005 (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.
Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.
Detailed description
Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: COLD-fX natural health product200 mg COLD-fX Natural health products 2 times daily for six months |
| Arm 2 | Active comparator | Dietary Supplement: COLD-fXArm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months |
| 3 | Placebo comparator | Other: PlaceboInactive crystalline substance. This is the placebo arm in which subject receive 200 mg of the placebo 2 times daily for 6 months. Placebo is an inactive crystalline substance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years of age and older
- current season influenza immunization
- available for follow-up visits
- willing and able to sign written informed consent
Key exclusion criteria (18 listed)
- HIV infection
- malignancy (under active observation or treatment)
- unstable cardiovascular diseases
- renal abnormalities (serum creatine >200umol/l)
- pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory illness)
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 |
|---|---|---|
| COLD-fX natural health productAlso: Natural health product, dietary supplement200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months | Dietary supplement | 1 |
| COLD-fXAlso: naural health products, dietary supplements400 mg COLD-fX natural health product 2 times daily for 6 months | Dietary supplement | Arm 2 |
| PlaceboAlso: none availablecrystalline substance 200 mg twice daily for 6 months | Other | 3 |
Primary outcome
To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
Time frame: During the study time frame of 6 months
1 secondary outcome
To evaluate the effects of the treatment on the incidence and frequency of all respiratory infections meeting the Jackson criteria and to determine the efficacy of COLD-fX supplementation on the severity and duration of symptoms.
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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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.
Gerry Predy, MD principal investigator
Capital Health, Canada
Shelly McNeil MD principal investigator
IWK Health Centre
Jan McElhaney principal investigator
UBC Gerontology and Diabetes Research
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COLD-fX natural health product and COLD-fX in people with Respiratory Tract Infection, run by Capital Health, Canada at 5 sites in 2 countries.
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections. (time frame: During the study time frame of 6 months). 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 7 Jul 2011.