Clinical trial NCT00410280: Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
Official title: Allergen Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* generally healthy, men and women with mild allergic asthma, aged 18 to 60 years
* only asthma med is short-acting bronchodilator used not more than twice weekly
* FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion Criteria:

Primary outcomes:
measure: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening
timeFrame: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)
measure: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14
timeFrame: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14
measure: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35
timeFrame: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35
Secondary outcomes:
measure: Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)
timeFrame: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35
measure: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35
timeFrame: Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
measure: Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)
timeFrame: Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35
measure: Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge
timeFrame: Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge
measure: Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35
timeFrame: Baseline, Day 14, 35
measure: Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline
timeFrame: Baseline
measure: Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168
timeFrame: Baseline, Day 13, 34, 56, 112, 168
measure: Total Blood Eosinophil Counts at Baseline
timeFrame: Baseline
measure: Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168
timeFrame: Baseline, Day 8, 13, 21, 34, 56, 84, 168
measure: Blood Levels of Interleukin-13 (IL-13)
timeFrame: Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood
timeFrame: Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112
measure: Protein Expression in Sputum and Blood
timeFrame: Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112
measure: Maximum Observed Serum Concentration (Cmax) for IMA-638
timeFrame: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638
timeFrame: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638
timeFrame: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638
timeFrame: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Serum Decay Half-Life (t1/2) for IMA-638
timeFrame: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168
measure: Number of Participants With Antibodies to IMA-638
timeFrame: Baseline up to Day 168
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University Medical
state: Ontario
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5.