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Mild Allergic AsthmaPhase 2NCT01092403

Safety, Tolerability and Clinical Activity of ASM-024 in Subjects With Mild Allergic Asthma

A Phase 2 study testing ASM-024 in people with Mild Allergic Asthma, run by Asmacure Ltée at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic asthma. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Mild Allergic Asthma
What is being tested?
ASM-024
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
3 sitesCanada
Study dates
Apr 2010to Jan 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 50 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 ≤ 50 years of age;
  • Female subjects of childbearing potential must have a negative pregnancy test (serum b-HCG) at Pre-Screening, and a negative urine pregnancy test immediately before the first administration of the study drug for each of the three Treatment Periods. Sexually active females 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 a IUD. Male subjects must ensure that their female partner is willing to use adequate contraception;
  • Diagnosis of mild allergic asthma that meets the following criteria:
  • Stable on inhaled short-acting beta-2-agonists p.r.n. as the only medication for asthma.
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  • Presence of both early asthmatic response (EAR) (at least 20 % fall in FEV1 within 3 hours after allergen inhalation) and late asthmatic response (LAR) (at least 15 % fall in FEV1).
  • Baseline methacholine (PC20) ≤ 16 mg/mL.
  • FEV1 of at least 70 % of the predicted value at Pre-Screening and Screening / Baseline;
  • BMI ≥ 19 and ≤ 35 kg/m²;
  • Body weight ≥ 40 kg;
  • Positive skin prick test to at least one common aeroallergen.

Who cannot join

  • Any lung disease other than mild allergic asthma;
  • Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Pre-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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence or a partner who has undergone a vasectomy;
  • Respiratory tract infections or worsening of asthma within 6 weeks before Screening/Baseline;
  • Baseline methacholine PC20 > 16 mg/mL at Screening / Baseline;
  • Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within the 12 months preceding enrolment in the study;
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  • Use of any nicotine containing products within 6 months before Pre-Screening;
  • Any of the following concomitant medications:
  • Any medication that are known to prolong QT / QTc interval.
  • Oral or inhaled corticosteroids within 28 days preceding Pre-Screening or systemic corticosteroids within 90 days of Pre-Screening.
  • Long acting beta-2-agonists within one week preceding Baseline.
  • Use of inhaled short-acting β2- agonists or anticholinergics within 8 hours before all study visits to the clinic.
  • Known or suspected allergy or sensitivity to nicotine or cholinergic drugs or any drug with similar chemical structure;
  • Clinically significant ECG abnormalities at Pre-Screening including clinically significant or marked baseline prolongation of QT / QTc interval (e.g. repeated demonstration of a QTc interval of > 450 ms). Other non clinically significant findings such as sinus bradycardia, sinus arrhythmia, borderline first degree AV block (up to 205 ms), left ventricular hypertrophy (on voltage criteria for a subject less than 40 years old for instance) are permissible if judged to be acceptable by the Qualified investigator;
  • Family history of additional risk factors for TdP (e.g., family history of Long QT Syndrome.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Mc Master University Health Sciences Center

    Hamilton, Quebec, L8N 3Z5

  • Centre de Recherche - Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec, G1V 4G5

  • University of Saskatechewan

    Saskatoon, Saskatchewan, S7N0W8

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Inhalation Once Daily to Subjects With Mild Allergic Asthma

The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic asthma.

Being tested
ASM-024, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASM-024Drug

    ASM-024 50 mg of ASM-024 or 200 mg once daily by inhalation

  • PlaceboDrug

    Placebo once daily by inhalation

Study groups in NCT01092403
Study groupRoleWhat they receive
ASM-024ExperimentalASM-024 once daily by inhalation
Receives: Drug: ASM-024
PlaceboPlacebo comparatorPlacebo once daily by inhalation
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late asthmatic response (LAR)

    LAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge

    Measured: Day 8 of each treatment period

  2. Early asthmatic response (EAR)

    EAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge

    Measured: Day 8 of every treatment period

  3. Airway hyperresponsiveness

    Difference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge

    Measured: Days -1, 7 and 9 of each treatment period

  4. Safety and tolerability

    Measured: Physical examination: Day 9, vital signs: Days -1, 1, 7, 8 and 9; twelve-lead ECG: Days 1, 7, 8 and 9 , AEs throughout the study, safety laboratory assessments Day 1 and 9 and Chest X-Ray: Day 9 of the final treatment period

Secondary outcomes (7)

  1. LAR's FEV1 AUC

    From 3 to 7 hours post-allergen challenge

    Measured: Day 8 of every treatment period

  2. FEV1

    24 hours post-allergen challenge

    Measured: Day 9

  3. EAR's FEV1 AUC

    From 0 to 3 hours post-allergen challenge

    Measured: Day 8

  4. Change in FEV1

    Before inhalation of ASM-024 and as soon as possible following inhalation of ASM-024

    Measured: Days 1, 7, 8 and 9

  5. Induced sputum eosinophil count and eosinophil and neutrophil percentages

    Measured: Days -1, 7 and 9 of every Treatment Period

  6. Blood eosinophil count

    Measured: Days -1 and 9 of every Treatment Period

  7. Total and differential WBC count

    Measured: Days -1 and 9 of every Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionDec 2011
  4. Study completionJan 2012

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01092403
Sponsor's protocol ID
ASM-024/II/STA-01
Status last verified
Jan 2012
First submitted
23 Mar 2010
Last updated
26 Jan 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASM-024 in people with Mild Allergic 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 12 inclusion and 15 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 26 Jan 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?

Late asthmatic response (LAR) (time frame: Day 8 of each treatment period). The study lists 4 primary outcomes in all. 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 NCT01092403.

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 26 Jan 2012.

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