Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Other: placebo; Biological: IMA-638

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425061

3174K1-201

B2421007 (Other Identifier)

Details and patient eligibility

About

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.

Enrollment: 159 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
• History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
• FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: IMA-638

Biological: IMA-638

2

Experimental group

Treatment:

Biological: IMA-638

Biological: IMA-638

3

Placebo Comparator group

Treatment:

Other: placebo