COPDPhase 2NCT01855230
Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing ASM-024 in people with COPD, run by Asmacure Ltée at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and clinical activity of ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or GOLD 3 COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- ASM-024
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Dec 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult aged over 40 yrs with a clinically confirmed diagnosis of COPD at the severity stages of GOLD 2 (moderate) or 3 (severe);
- Stable COPD for 1 month prior to screening
- Stable smoker for at least three months prior to screening, or non-smoker, with a smoking history of ≥ 10 packs years;
- FEV₁ ≥ 30 % and < 70 % of the predicted normal value;
- Normal 12-lead ECG
Who cannot join
- Clinically significant illness except COPD 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;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval;
Show all 13Show fewer
- Clinically significant 12 lead ECG at screening;
- Clinically significant physical examination or laboratory findings or abnormal vital signs;
- History of alcohol or drug abuse;
- Positive hepatitis B or C or HIV test at Screening;
- 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
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Two-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Dry Power Inhalation to Patients With GOLD 2 (Moderate) or GOLD 3 (Severe) Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate the safety, tolerability, and clinical activity of ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or GOLD 3 COPD.
Read the detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, two-way crossover study to evaluate the safety, tolerability, and clinical activity of a new, dry powder for inhalation formulation of ASM-024 administered twice daily for 14 days to patients with GOLD-2 or GOLD-3 COPD.
- Conditions
- COPD
- Being tested
- ASM-024, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASM-024Drug
ASM-024 b.i.d for 14 days
PlaceboDrug
Placebo b.i.d. for 14 days
| Study group | Role | What they receive |
|---|---|---|
| ASM-024 | Experimental | Dry Powder for Inhalation, b.i.d., 14 days Receives: Drug: ASM-024 |
| Placebo | Placebo comparator | Dry Powder for Inhalation, b.i.d., 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV₁ AUC (0 -6 h)
Measured: Day 14
Secondary outcomes (8)
Change from baseline in Residual Volume (RV)
Measured: Days 1, 2, 3, & 14
Peak change in FEV₁
Measured: Days 1, 2, 3, & 14
Change from baseline in Inspiratory Capacity (IC)
Measured: Days 1, 2, 3, & 14
Change from baseline in Functional Residual Capacity (FRC)
Measured: Days 1, 2, 3, &14
Change from baseline in FEV₁
Measured: Day 14
Change from baseline in FEV₁/FVC
Measured: Days 1, 2, 3, & 14
FVC AUC (0-6 h)
Measured: Days 1, 2, 3, & 14
Use of rescue medication
Measured: From Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 14 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
- NCT01855230
- Sponsor's protocol ID
- ASM-024/II/STA-04
- Status last verified
- Dec 2014
- First submitted
- 10 May 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Two-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Dry Power Inhalation to Patients With GOLD 2 (Moderate) or GOLD 3 (Severe) Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01855230
- Acronym / sponsor ID
- ASM-024/II/STA-04
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Asmacure LtéeIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 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, tolerability, and clinical activity of ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or GOLD 3 COPD.
Detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, two-way crossover study to evaluate the safety, tolerability, and clinical activity of a new, dry powder for inhalation formulation of ASM-024 administered twice daily for 14 days to patients with GOLD-2 or GOLD-3 COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASM-024 | Experimental | Drug: ASM-024Dry Powder for Inhalation, b.i.d., 14 days |
| Placebo | Placebo comparator | Drug: PlaceboDry Powder for Inhalation, b.i.d., 14 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adult aged over 40 yrs with a clinically confirmed diagnosis of COPD at the severity stages of GOLD 2 (moderate) or 3 (severe);
- Stable COPD for 1 month prior to screening
- Stable smoker for at least three months prior to screening, or non-smoker, with a smoking history of ≥ 10 packs years;
- FEV₁ ≥ 30 % and < 70 % of the predicted normal value;
- Normal 12-lead ECG
Key exclusion criteria (13 listed)
- Clinically significant illness except COPD 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;
- Positive pregnancy test for female subjects;
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-024ASM-024 b.i.d for 14 days | Drug | ASM-024 |
| PlaceboPlacebo b.i.d. for 14 days | Drug | Placebo |
Primary outcome
FEV₁ AUC (0 -6 h)
Time frame: Day 14
8 secondary outcomes
Change from baseline in Residual Volume (RV)
Time frame: Days 1, 2, 3, & 14
Peak change in FEV₁
Time frame: Days 1, 2, 3, & 14
Change from baseline in Inspiratory Capacity (IC)
Time frame: Days 1, 2, 3, & 14
Change from baseline in Functional Residual Capacity (FRC)
Time frame: Days 1, 2, 3, &14
Change from baseline in FEV₁
Time frame: Day 14
Change from baseline in FEV₁/FVC
Time frame: Days 1, 2, 3, & 14
FVC AUC (0-6 h)
Time frame: Days 1, 2, 3, & 14
Use of rescue medication
Time frame: From Day 1 to Day 14
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 16 Dec 2014.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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
1 site 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 in people with COPD, run by Asmacure Ltée at 1 site 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 13 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 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
FEV₁ AUC (0 -6 h) (time frame: Day 14). 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 16 Dec 2014.