AsthmaPhase 1/2NCT01793298
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma
A Phase 1/2 study testing ASM-024 in people with Asthma, run by Asmacure Ltée at 2 sites in Canada.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- ASM-024
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2013to Dec 2014
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers:
- Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
- Normal lung function; and
- Normal 12-lead ECG
- Asthmatics:
- Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
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- Non-smoker or former smoker;
- FEV1 ≥ 70 % predicted in the absence of medications for asthma;
- Baseline methacholine PC20 ≤ 16 mg/mL; and
- Normal 12-lead ECG.
Who cannot join
- Healthy Volunteers:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
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- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval within 14 days prior to the first administration of the study medication;
- Clinically significant 12 lead ECG abnormalities at Screening;;
- Clinically significant physical examination or laboratory findings at Screening;
- History of alcohol or drug abuse;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Investigational drug within 30 days prior to first administration of the study medication, or long-acting investigational drug within 90 days prior to first administration of the study medication;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
- Asthmatics:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval;
- Clinically significant 12 lead ECG at Screening;
- Clinically significant physical examination or laboratory findings or abnormal vital signs;
- Baseline methacholine PC20 > 16 mg/mL at Screening;
- History of illicit drug use or alcohol abuse within 12 months of Screening;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Any of the following concomitant medications preceding the administration of methacholine during Screening and preceding the administration of the study medication at Visit 1: (i) oral or i.v. corticosteroids within 1 month; (ii) inhaled or intranasal corticosteroids within 48 hours; (iii) long-acting beta-2-agonists within 48 hours; (iv) short-acting beta-2-agonists within 8 hours; (v) anticholinergic aerosol within 24 hours; (vi) theophyline-containing products within 48 hours; (vii) NSAIDs within 7 days preceding the administration of methacholine during Screening and throughout the study; and (viii) antihistaminic drugs within 3 days;
- Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of Screening;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
PharmaNet
Québec, Quebec, G1P 0A2
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ASM-024 Administered by Dry Powder Inhalation to Healthy Subjects and Subjects With Stable Moderate Asthma
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
Read the detailed description
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma. The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024. The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers. In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
- Conditions
- Asthma
- Being tested
- ASM-024
- 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
Ascending doses of ASM-024
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects - ASM-024 Single Administration | Experimental | Single administration of ascending doses of ASM-024 Receives: Drug: ASM-024 |
| Healthy Subjects - Placebo | Placebo comparator | Single administration of placebo |
| Healthy Subjects - ASM-024 Repeat Administration | Experimental | Repeat administration of ascending doses of ASM-024 Receives: Drug: ASM-024 |
| Healthy Subjects - Placebo Repeat Administration | Placebo comparator | Repeat administration of ascending doses of placebo |
| Subjects with Asthma | Experimental | Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion Receives: Drug: ASM-024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events, spirometry
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionDec 2014
Why it stopped: Lack of efficacy
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmacure Ltée
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvon Cormier, M.D., Study chair, Asmacure Ltée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793298
- Sponsor's protocol ID
- ASM-024/I-II/STA-03
- Status last verified
- Feb 2015
- First submitted
- 14 Feb 2013
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ASM-024 Administered by Dry Powder Inhalation to Healthy Subjects and Subjects With Stable Moderate Asthma
- ClinicalTrials.gov ID
- NCT01793298
- Acronym / sponsor ID
- ASM-024/I-II/STA-03
- Conditions
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Asmacure LtéeIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 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.
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
Detailed description
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma. The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024. The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers. In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects - ASM-024 Single Administration | Experimental | Drug: ASM-024Single administration of ascending doses of ASM-024 |
| Healthy Subjects - Placebo | Placebo comparator | –Single administration of placebo |
| Healthy Subjects - ASM-024 Repeat Administration | Experimental | Drug: ASM-024Repeat administration of ascending doses of ASM-024 |
| Healthy Subjects - Placebo Repeat Administration | Placebo comparator | –Repeat administration of ascending doses of placebo |
| Subjects with Asthma | Experimental | Drug: ASM-024Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
- Normal lung function; and
- Normal 12-lead ECG
- Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
- Non-smoker or former smoker;
Key exclusion criteria (34 listed)
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
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-024Ascending doses of ASM-024 | Drug | Healthy Subjects - ASM-024 Repeat Administration, Healthy Subjects - ASM-024 Single Administration, Subjects with Asthma |
Primary outcome
adverse events, spirometry
Time frame: up to 7 days
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Yvon Cormier, M.D. study chair
Asmacure Ltée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASM-024 in people with Asthma, run by Asmacure Ltée at 2 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 10 inclusion and 34 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Lack of efficacy). 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?
adverse events, spirometry (time frame: up to 7 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 10 Feb 2015.