Safety and Efficacy of WIN-901X in Asthma

Whanin Pharmaceutical Company

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: WIN-901X dose level 1; Drug: WIN-901X dose level 2; Drug: Placebo; Drug: WIN-901X dose level 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820481

WIN-901X-P2

Details and patient eligibility

About

This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Full description

Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients

Enrollment: 209 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 20 and less than 80 years of age
• Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
• FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
• No history of smoking at least one year prior to the screening
• Having voluntarily signed an informed consent

Exclusion criteria

• Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
• Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
• Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
• Have malignant tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 4 patient groups, including a placebo group

Treatment 1

Experimental group

Treatment:

Drug: WIN-901X dose level 1

Treatment 2

Experimental group

Treatment:

Drug: WIN-901X dose level 2

Treatment 3

Experimental group

Treatment:

Drug: WIN-901X dose level 3

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo