Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158898
• Other study ID #: TPI ASM8-207
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2010
• Last updated: November 14, 2013
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: November 2013
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TPI ASM8
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
• TPI ASM8
ASM8 4mg/mL (high dose) daily for 14 days by inhalation
• TPI ASM8
Placebo PBS solution daily for 14 days by inhalation

Locations

Country	Name	City	State
Canada	Health Research Innovation Centre	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	Laval Centre de Pneumologie Chest Division	Quebec
Canada	Vancouver Coastal Health Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the AUC of the late asthmatic response (LAR) between treatments and placebo	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	Day 14 (Between 3-7 hr post-AIC)	No
Secondary	Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment	Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.	Day 14	No
Secondary	Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge	We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1	Day 13 and Day 15 (Pre & post AIC)	Yes
Secondary	Effect of ASM8 on mast cells (as measured by specific biomarkers)	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	Day 14 (pre, post and and peri-AIC)	No
Secondary	Sputum inflammation indicators (Eos, neutrophils, etc.)	We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.	Day 14 and Day 15	No