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NCT Number: NCT01158898

Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Health Research Innovation Centre, Calgary, Alberta, Canada

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About this study

Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild asthma, male and female aged 18-55 y.old
  • Steroid-naive, non-smoker
  • Dual responders

Exclusion criteria

  • Any chronic disease(unstable)
  • Immunosuppressed, recent or ongoing steroid intake
  • Methacholine PC 20 > 16 mg/mL

Treatment and study plan

TPI ASM8

Drug

ASM8 4mg/mL (low dose) daily for 14 days by inhalation

Primary outcomes

  1. Compare the AUC of the late asthmatic response (LAR) between treatments and placebo

    Time frame: Day 14 (Between 3-7 hr post-AIC)

    The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo

Secondary outcomes

  1. Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment

    Time frame: Day 14

    Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.

  2. Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge

    Time frame: Day 13 and Day 15 (Pre & post AIC)

    We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1

  3. Effect of ASM8 on mast cells (as measured by specific biomarkers)

    Time frame: Day 14 (pre, post and and peri-AIC)

    The leukotriene E4 and 9-11B PGF2 wil be measured in urine and plasma to determine the level of mast cells activation following the allergen challenge

  4. Sputum inflammation indicators (Eos, neutrophils, etc.)

    Time frame: Day 14 and Day 15

    We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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