Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

Asthma Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00530166
• Other study ID #: CR013087
• Secondary ID: 18054478NAP2002
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2007
• Last updated: June 3, 2014
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.

Description:

Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Medically confirmed diagnosis of persistent asthma

• Able to demonstrate reversibility of at least 12% with albuterol inhalation

• Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior

• Able to produce an FEV1 between 45 and 85% of predicted

• Willing to perform study procedures for about 14 weeks.

Exclusion Criteria:

• Use of inhaled corticosteroids within 4 weeks

• Use of oral/parenteral corticosteroids within 8 weeks

• Use of long-acting beta-2 agonists or montelukast within 2 weeks

• History of life-threatening asthma attack within 3 months

• Female of child bearing potential.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• JNJ-18054478
3(100 mg) tablets once daily for 12 weeks
• sham comparator
3(100 mg) tablets once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Costa Rica,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.		12 weeks	Yes
Secondary	The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478		12 weeks	Yes