AsthmaPhase 2NCT00232999
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
A Phase 2 study testing Nebulized IVX-0142 in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in Canada.
Trial summary
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulized IVX-0142
- How many people
- 15 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2005to Jan 2006
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild stable allergic asthma
- Positive skin-prick test to at least one common aeroallergen
- Positive methacholine challenge
- Positive allergen-induced early- and late-phase airway bronchoconstriction
- General good health
Who cannot join
- Lung diseases other than mild allergic asthma
- History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
- Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
- Use of tobacco products within one year starting study or smoking history >10 pack years
- If female, pregnant or lactating or have positive pregnancy test at screening
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Department of Medicine, McMaster University
Hamilton, Ontario, L8N 3Z5
Centre de cardiology et de pneumologie de l'Universite Laval
Sainte-Foy (Quebec City), Quebec, G1V 4G5
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.
- Conditions
- Asthma
- Being tested
- Nebulized IVX-0142
- Keywords
- Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
- Medical subject headings
- Asthma, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized IVX-0142Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
Secondary outcomes (2)
Methacholine PC20 pre- and post-allergen challenge
Anti-inflammatory activity in airways
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AllerGen NCE Inc.
- Responsible party
- Sponsor
- Investigators
- Paul M O'Byrne, MD, Principal investigator, McMaster University and AllerGen NCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232999
- Sponsor's protocol ID
- IXR-201-04-142
- Status last verified
- Nov 2021
- First submitted
- 4 Oct 2005
- Last updated
- 12 Nov 2021
- Results posted
- No
Publications
Duong M, Cockcroft D, Boulet LP, Ahmed T, Iverson H, Atkinson DC, Stahl EG, Watson R, Davis B, Milot J, Gauvreau GM, O'Byrne PM. The effect of IVX-0142, a heparin-derived hypersulfated disaccharide, on the allergic airway responses in asthma. Allergy. 2008 Sep;63(9):1195-201. doi: 10.1111/j.1398-9995.2008.01707.x.
PubMed 18699936
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT00232999
- Acronym / sponsor ID
- IXR-201-04-142
- Conditions
- Asthma
- Keywords
- Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AllerGen NCE Inc.
- Study start
- Oct 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 5 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.
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mild stable allergic asthma
- Positive skin-prick test to at least one common aeroallergen
- Positive methacholine challenge
- Positive allergen-induced early- and late-phase airway bronchoconstriction
- General good health
Key exclusion criteria (5 listed)
- Lung diseases other than mild allergic asthma
- History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
- Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
- Use of tobacco products within one year starting study or smoking history >10 pack years
- If female, pregnant or lactating or have positive pregnancy test at screening
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 |
|---|---|---|
| Nebulized IVX-0142 | Drug | – |
Primary outcome
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
2 secondary outcomes
Methacholine PC20 pre- and post-allergen challenge
Anti-inflammatory activity in airways
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 12 Nov 2021.
- Results publication: PubMed 18699936Duong M, Cockcroft D, Boulet LP, Ahmed T, Iverson H, Atkinson DC, Stahl EG, Watson R, Davis B, Milot J, Gauvreau GM, O'Byrne PM. The effect of IVX-0142, a heparin-derived hypersulfated disaccharide, on the allergic airway responses in asthma. Allergy. 2008 Sep;63(9):1195-201. doi: 10.1111/j.1398-9995.2008.01707.x.
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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.
Paul M O'Byrne, MD principal investigator
McMaster University and AllerGen NCE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nebulized IVX-0142 in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in Canada.
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 5 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00232999, which also lists 1 linked publication.
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 Nov 2021.