Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma

Asmacure Ltée

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: ASM-024 100 mg; Drug: Placebo; Drug: ASM-024

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190826

ASM-024/II/STA-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

ASM-024 10 mg

Experimental group

Description:

ASM-024 administered once by inhalation at a target dose of 10 mg

Treatment:

Drug: ASM-024

ASM-024 100 mg

Experimental group

Description:

ASM-024 administered once at a target dose of 100 mg

Treatment:

Drug: ASM-024 100 mg

Placebo

Placebo Comparator group

Description:

Placebo administered once by inhalation

Treatment:

Drug: Placebo