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Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT01158898
First received: June 17, 2010
Last updated: February 2, 2012
Last verified: February 2012
History of Changes

June 17, 2010
February 2, 2012
November 2010
December 2011   (final data collection date for primary outcome measure)
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo [ Time Frame: Day 14 (Between 3-7 hr post-AIC) ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01158898 on ClinicalTrials.gov Archive Site
  • Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.
  • Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge [ Time Frame: Day 13 and Day 15 (Pre & post AIC) ] [ Designated as safety issue: Yes ]
    We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1
  • Effect of ASM8 on mast cells (as measured by specific biomarkers) [ Time Frame: Day 14 (pre, post and and peri-AIC) ] [ Designated as safety issue: No ]
    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
  • Sputum inflammation indicators (Eos, neutrophils, etc.) [ Time Frame: Day 14 and Day 15 ] [ Designated as safety issue: No ]
    We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
  • Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.
  • Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge [ Time Frame: Day 13 and Day 15 (Pre & post AIC) ] [ Designated as safety issue: Yes ]
    We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1
  • Effect of ASM8 on mast cells (as measured by specific biomarkers) [ Time Frame: Day 14 (pre, post and and peri-AIC) ] [ Designated as safety issue: No ]
    The leukotriene E4 and 9-1,11BPGF2 wil be mesured in urine and plasma to determine the level of mast cells activation following the allergen challenge
  • Sputum inflammation indicators (Eos, neutrophils, etc.) [ Time Frame: Day 14 and Day 15 ] [ Designated as safety issue: No ]
    We wil mesure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
Not Provided
Not Provided
 
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: TPI ASM8
    ASM8 4mg/mL (low dose) daily for 14 days by inhalation
  • Drug: TPI ASM8
    ASM8 4mg/mL (high dose) daily for 14 days by inhalation
  • Drug: TPI ASM8
    Placebo PBS solution daily for 14 days by inhalation
  • Active Comparator: TPI ASM8 low dose
    Intervention: Drug: TPI ASM8
  • Active Comparator: TPI ASM8 high dose
    Intervention: Drug: TPI ASM8
  • Placebo Comparator: Placebo
    Intervention: Drug: TPI ASM8
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
February 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01158898
TPI ASM8-207
No
Pharmaxis
Pharmaxis
Not Provided
Study Chair: Paul O'Byrne, MD McMaster University
Study Director: Rene Pageau, M.Sc Pharm Pharmaxis Ltd
Principal Investigator: Louis-Philippe Boulet, MD Hopital Laval, Quebec
Principal Investigator: Richard Leigh, MD University of Calgary
Principal Investigator: Gail M Gauveau, PhD McMaster University
Principal Investigator: Mark Fitzgerald, MD Vancouver Coastal Health Research Institute
Pharmaxis
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP