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

This study has been completed.
Information provided by (Responsible Party):
Asmacure Ltée Identifier:
First received: March 23, 2010
Last updated: January 25, 2012
Last verified: January 2012
The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic asthma.

Condition Intervention Phase
Mild Allergic Asthma Drug: ASM-024 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Asmacure Ltée:

Primary Outcome Measures:
  • Late asthmatic response (LAR) [ Time Frame: Day 8 of each treatment period ]
    LAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge

  • Early asthmatic response (EAR) [ Time Frame: Day 8 of every treatment period ]
    EAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge

  • Airway hyperresponsiveness [ Time Frame: Days -1, 7 and 9 of each treatment period ]
    Difference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge

  • Safety and tolerability [ Time Frame: 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 Outcome Measures:
  • LAR's FEV1 AUC [ Time Frame: Day 8 of every treatment period ]
    From 3 to 7 hours post-allergen challenge

  • FEV1 [ Time Frame: Day 9 ]
    24 hours post-allergen challenge

  • EAR's FEV1 AUC [ Time Frame: Day 8 ]
    From 0 to 3 hours post-allergen challenge

  • Change in FEV1 [ Time Frame: Days 1, 7, 8 and 9 ]
    Before inhalation of ASM-024 and as soon as possible following inhalation of ASM-024

  • Induced sputum eosinophil count and eosinophil and neutrophil percentages [ Time Frame: Days -1, 7 and 9 of every Treatment Period ]
  • Blood eosinophil count [ Time Frame: Days -1 and 9 of every Treatment Period ]
  • Total and differential WBC count [ Time Frame: Days -1 and 9 of every Treatment Period ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASM-024
ASM-024 once daily by inhalation
Drug: ASM-024
ASM-024 50 mg of ASM-024 or 200 mg once daily by inhalation
Placebo Comparator: Placebo
Placebo once daily by inhalation
Drug: Placebo
Placebo once daily by inhalation


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
    • 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.

Exclusion Criteria:

  • 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;
  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01092403

Canada, Quebec
Mc Master University Health Sciences Center
Hamilton, Quebec, Canada, L8N 3Z5
Centre de Recherche - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
University of Saskatechewan
Saskatoon, Saskatchewan, Canada, S7N0W8
Sponsors and Collaborators
Asmacure Ltée
Principal Investigator: Louis-Philippe Boulet, MD Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

Responsible Party: Asmacure Ltée Identifier: NCT01092403     History of Changes
Other Study ID Numbers: ASM-024/II/STA-01
Study First Received: March 23, 2010
Last Updated: January 25, 2012

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 18, 2017