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

NCT01092403 | Completed Phase 2

• 1 other identifier: ASM-024/II/STA-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Mild Allergic Asthma

Outcome Measures

Primary Outcomes (4)

• Late asthmatic response (LAR)

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

  Day 8 of each treatment period

• Early asthmatic response (EAR)

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

  Day 8 of every treatment period

• Airway hyperresponsiveness

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

  Days -1, 7 and 9 of each treatment period

• Safety and tolerability

  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)

• LAR's FEV1 AUC

  Day 8 of every treatment period

• FEV1

  Day 9

• EAR's FEV1 AUC

  Day 8

• Change in FEV1

  Days 1, 7, 8 and 9

• Induced sputum eosinophil count and eosinophil and neutrophil percentages

  Days -1, 7 and 9 of every Treatment Period

Study Arms (2)

ASM-024

EXPERIMENTAL

ASM-024 once daily by inhalation

Drug: ASM-024

Placebo

PLACEBO COMPARATOR

Placebo once daily by inhalation

Drug: Placebo

Interventions

ASM-024 DRUG

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

ASM-024

Placebo DRUG

Placebo once daily by inhalation

Placebo

Eligibility Criteria

• Age: 18 Years - 50 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 ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asmacure Ltée: lead

Study Sites (3)

Mc Master University Health Sciences Center

Hamilton, Quebec, L8N 3Z5, Canada

Location

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

Québec, Quebec, G1V 4G5, Canada

Location

University of Saskatechewan

Saskatoon, Saskatchewan, S7N0W8, Canada

Location

MeSH Terms

Interventions

ASM-024

Study Officials

• Louis-Philippe Boulet, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

CA (3)