AsthmaPhase 2NCT01190826
Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
A Phase 2 study testing ASM-024 and ASM-024 100 mg in people with Asthma, run by Asmacure Ltée at 3 sites in Canada.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- ASM-024 and ASM-024 100 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2010to Feb 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to provide written informed consent.
- Male or female subjects, ≥ 18 years and ≤ 55 years of age
- Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
- FEV1 ≥ 55 % predicted in the absence of medications for asthma
- Female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-HCG)) at Screening, and a negative pregnancy test immediately before the administration of the study drug for each of Periods 1, 2 and 3. Sexually active females with non-sterile partner must be willing to use adequate contraception.
- Male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an intra-uterine device (IUD). Male subjects must ensure that their female partner is willing to use adequate contraception.
- Demonstration of an increase in FEV1 by ≥ 10 % predicted between spirometry performed before and 10-20 minutes after the administration of 2 puffs of 100 micrograms of salbutamol at Screening.
Who cannot join
- Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
- Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
- Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
- Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
- Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
- Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within 12 months preceding enrolment in the study.
Show all 20Show fewer
- Positive urine cotinine test at Screening.
- History of illicit drug use or alcohol abuse within 12 months before Screening.
- Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
- Any medication that are known to prolong QT / QTc interval.
- Any of the following concomitant medications preceding the administration of salbutamol during Screening and preceding the administration of the study drug:
- Oral or i.v. corticosteroids within 1 month;
- Inhaled or intranasal corticosteroids within 48 hours;
- Long acting Beta-2-agonists within 24 hours;
- Short acting Beta-2-agonists within 8 hours;
- Anticholinergic aerosols within 24 hours; and
- Theophylline-containing products within 48 hours.
- Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
- Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
- Use of an investigational product or participation in a clinical trial using an investigational product within 30 days before dosing or within 90 days in the case of long-acting products (ex.: Depo-medrol) or biologics with a long-acting half-life (ex.: monoclonal antibodies).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
Anapharm
Montreal, Quebec, H3X 2H9
Centre de Recherche Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Single-Center, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of a Single Dose of ASM-024 Administered by Inhalation to Subjects With Stable Moderate Asthma
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.
- Conditions
- Asthma
- Being tested
- ASM-024, ASM-024 100 mg, Placebo
- Keywords
- Stable moderate asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASM-024Drug
Target dose of 10 mg ASM-024 administered once by inhalation
ASM-024 100 mgDrug
Target dose of 100 mg ASM-024 administered once by inhalation
PlaceboDrug
Placebo administered once by inhalation
| Study group | Role | What they receive |
|---|---|---|
| ASM-024 10 mg | Experimental | ASM-024 administered once by inhalation at a target dose of 10 mg Receives: Drug: ASM-024 |
| ASM-024 100 mg | Experimental | ASM-024 administered once at a target dose of 100 mg Receives: Drug: ASM-024 100 mg |
| Placebo | Placebo comparator | Placebo administered once by inhalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak change in FEV1 following inhalation of ASM-024
Measured: Over a period of 6 hours following administration
Secondary outcomes (1)
FEV1 AUC following inhalation of ASM-024
Measured: Over 6 hours following administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionFeb 2012
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmacure Ltée
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Larouche, B. Pharm. MD, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190826
- Sponsor's protocol ID
- ASM-024/II/STA-02
- Status last verified
- Mar 2012
- First submitted
- 26 Aug 2010
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of a Single Dose of ASM-024 Administered by Inhalation to Subjects With Stable Moderate Asthma
- ClinicalTrials.gov ID
- NCT01190826
- Acronym / sponsor ID
- ASM-024/II/STA-02
- Conditions
- Asthma
- Keywords
- Stable moderate asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asmacure LtéeIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Aug 2010 (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.
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASM-024 10 mg | Experimental | Drug: ASM-024ASM-024 administered once by inhalation at a target dose of 10 mg |
| ASM-024 100 mg | Experimental | Drug: ASM-024 100 mgASM-024 administered once at a target dose of 100 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered once by inhalation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able and willing to provide written informed consent.
- Male or female subjects, ≥ 18 years and ≤ 55 years of age
- Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
- FEV1 ≥ 55 % predicted in the absence of medications for asthma
- Female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-HCG)) at Screening, and a negative pregnancy test immediately before the administration of the study drug for each of Periods 1, 2 and 3. Sexually active females with non-sterile partner must be willing to use adequate contraception.
Key exclusion criteria (20 listed)
- Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
- Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
- Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
- Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
- Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
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 |
|---|---|---|
| ASM-024Target dose of 10 mg ASM-024 administered once by inhalation | Drug | ASM-024 10 mg |
| ASM-024 100 mgTarget dose of 100 mg ASM-024 administered once by inhalation | Drug | ASM-024 100 mg |
| PlaceboPlacebo administered once by inhalation | Drug | Placebo |
Primary outcome
Peak change in FEV1 following inhalation of ASM-024
Time frame: Over a period of 6 hours following administration
1 secondary outcome
FEV1 AUC following inhalation of ASM-024
Time frame: Over 6 hours following administration
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 15 Mar 2012.
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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.
Richard Larouche, B. Pharm. MD principal investigator
Anapharm
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 ASM-024 and ASM-024 100 mg in people with Asthma, run by Asmacure Ltée 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 7 inclusion and 20 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 15 Mar 2012. 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?
Peak change in FEV1 following inhalation of ASM-024 (time frame: Over a period of 6 hours following administration). 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 15 Mar 2012.