Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
This study has been completed.
Sponsor:
Pharmaxis
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT01158898
First received: June 17, 2010
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: TPI ASM8 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pharmaxis:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Enrollment: | 16 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: TPI ASM8 low dose |
Drug: TPI ASM8
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
|
| Active Comparator: TPI ASM8 high dose |
Drug: TPI ASM8
ASM8 4mg/mL (high dose) daily for 14 days by inhalation
|
| Placebo Comparator: Placebo |
Drug: TPI ASM8
Placebo PBS solution daily for 14 days by inhalation
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158898
Locations
| Canada, Alberta | |
| Health Research Innovation Centre | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Canada, British Columbia | |
| Vancouver Coastal Health Research Institute | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada | |
| Laval Centre de Pneumologie Chest Division | |
| Quebec, Canada, G1V4G5 | |
Sponsors and Collaborators
Pharmaxis
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Pharmaxis |
| ClinicalTrials.gov Identifier: | NCT01158898 History of Changes |
| Other Study ID Numbers: | TPI ASM8-207 |
| Study First Received: | June 17, 2010 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Pharmaxis:
|
Mild to moderate asthma Allergen inhalation challenge |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013