Phase 2 N=27 Randomized Quadruple-blind Treatment

Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00410280 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening — 27.19; 20.47 percent drop

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IMA-638 is a biologic (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening	27.19; 20.47	—
PRIMARY Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14	12.84; 19.28	0.0947
PRIMARY Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35	11.32; 15.56	0.2673
SECONDARY 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)	57.57; 55.64; 25.48; 49.28; 21.94; 39.11	0.0391 sig
SECONDARY 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	33.23; 34.40; 20.40; 30.15; 22.76; 26.82	0.0423 sig
SECONDARY 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)	45.37; 50.39; 21.51; 40.56; 25.75; 38.94	0.0302 sig
SECONDARY 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	-1.37; -1.47; -0.63; -0.63; -0.71; -0.43	0.8469
SECONDARY Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35	—	—
SECONDARY Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline	259.7; 179.8	—
SECONDARY Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168	29.1; -4.4; 37.4; 1.5; 4.2; -14.2	—
SECONDARY Total Blood Eosinophil Counts at Baseline	0.276; 0.315	—
SECONDARY Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168	0.051; -0.112; 0.089; -0.056; 0.060; -0.008	—
SECONDARY Blood Levels of Interleukin-13 (IL-13)	—	—
SECONDARY Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood	—	—
SECONDARY Protein Expression in Sputum and Blood	—	—
SECONDARY Maximum Observed Serum Concentration (Cmax) for IMA-638	30.5	—
SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638	8.5	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638	32259.13	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638	32609.32	—
SECONDARY Serum Decay Half-Life (t1/2) for IMA-638	25.1	—
SECONDARY Number of Participants With Antibodies to IMA-638	0; 0	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00410280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.