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

NCT01190826 | Completed Phase 2

• 1 other identifier: ASM-024/II/STA-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Asthma

Keywords

Stable moderate asthma

Outcome Measures

Primary Outcomes (1)

• Peak change in FEV1 following inhalation of ASM-024

  Over a period of 6 hours following administration

Secondary Outcomes (1)

• FEV1 AUC following inhalation of ASM-024

  Over 6 hours following administration

Study Arms (3)

ASM-024 10 mg

EXPERIMENTAL

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

Drug: ASM-024

ASM-024 100 mg

EXPERIMENTAL

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

Drug: ASM-024 100 mg

Placebo

PLACEBO COMPARATOR

Placebo administered once by inhalation

Drug: Placebo

Interventions

ASM-024 DRUG

Target dose of 10 mg ASM-024 administered once by inhalation

ASM-024 10 mg

ASM-024 100 mg DRUG

Target dose of 100 mg ASM-024 administered once by inhalation

ASM-024 100 mg

Placebo DRUG

Placebo administered once by inhalation

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Asmacure Ltée: lead

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Anapharm

Montreal, Quebec, H3X 2H9, Canada

Location

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

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

ASM-024

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Richard Larouche, B. Pharm. MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

CA (3)