AsthmaPhase 2NCT00941577
Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
A Phase 2 study testing AIR645 and Physiologic saline solution in people with Asthma, run by Altair Therapeutics, Inc. at 3 sites in Canada.
Trial summary
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AIR645 and Physiologic saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2009to Jun 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with well controlled mild allergic asthma, aged 18 to 65 years
- Only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Study site
Hamilton, Ontario
Study site
Laval, Quebec
Study site
Saskatoon, Saskatchewan
About this study
Official title: A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.
- Conditions
- Asthma
- Being tested
- AIR645, Physiologic saline solution
- Keywords
- Hypersensitivity, Lung Diseases, Obstructive, Immune System Diseases, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases, Hypersensitivity, Immediate, Asthma, Respiratory Hypersensitivity
- Medical subject headings
- Asthma, Hypersensitivity, Lung Diseases, Obstructive, Immune System Diseases, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR645Drug
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Physiologic saline solutionDrug
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
| Study group | Role | What they receive |
|---|---|---|
| AIR645 | Experimental | AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) Receives: Drug: AIR645 |
| Physiologic saline solution | Placebo comparator | Physiologic saline solution Receives: Drug: Physiologic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altair Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mike Hodges, MD, Study director, Altair Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941577
- Sponsor's protocol ID
- AIR645-CS2
- Status last verified
- Jul 2010
- First submitted
- 15 Jul 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT00941577
- Acronym / sponsor ID
- AIR645-CS2
- Conditions
- Asthma
- Keywords
- Hypersensitivity, Lung Diseases, Obstructive, Immune System Diseases, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases, Hypersensitivity, Immediate, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Altair Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Jul 2009 (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.
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR645 | Experimental | Drug: AIR645AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) |
| Physiologic saline solution | Placebo comparator | Drug: Physiologic saline solutionPhysiologic saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with well controlled mild allergic asthma, aged 18 to 65 years
- Only asthma med is short-acting bronchodilator used not more than twice weekly
- FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AIR645AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. | Drug | AIR645 |
| Physiologic saline solutionPlacebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. | Drug | Physiologic saline solution |
Primary outcome
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo
Time frame: 36 days
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 23 Jul 2010.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Mike Hodges, MD study director
Altair Therapeutics, Inc.
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 AIR645 and Physiologic saline solution in people with Asthma, run by Altair Therapeutics, 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 3 inclusion and 0 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 23 Jul 2010. 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. 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 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?
Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo (time frame: 36 days). 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 23 Jul 2010.