A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

Asthma Clinical Trial

Official title:

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823016
• Other study ID #: CR100976
• Secondary ID: 38518168ASH20012
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2013
• Last updated: September 30, 2015
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Israeli Health Ministry Pharmaceutical AdministrationGermany: Ethics CommissionUnited States: Federal GovernmentGreat Britain: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: Research Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

Description:

This study will be randomized (treatment group assigned by chance, like flipping a coin), double-blind (study investigators and participants will not know what treatment is being administered), and placebo-controlled (a placebo is identical to the study agent, but contains no active ingredients). A total of 160 participants will receive either placebo or JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. Participant safety will be monitored throughout the entire study period..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1

• Have been receiving inhaled corticosteroid (ICS) (=1000 µg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1

• At Screening Visit 1, be receiving the same dose of ICS =1000 µg/day fluticasone (or equivalent) alone or in conjunction with long-acting ß2-agonist (LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening

• Have an Asthma Control Questionnaire (ACQ) score =1.5 at Screening Visit 1

• Have a prebronchodilator forced expiratory volume in 1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1

• Have a =12% relative change and =200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2

Exclusion Criteria:

• Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma

• Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease

• Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1; cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks of Screening Visit 1; theophylline within 4 weeks of Screening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1

• Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1

• Has smoked within 3 years of Screening Visit 1 or has a history of smoking = 10 pack years

• Body-Mass Index (BMI) greater than or equal to 40 kg/m2

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
Placebo tablet, taken once daily
• JNJ-38518168
JNJ-38518168, 30 mg tablet, taken once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)	Expressed as percent of predicted value.	Baseline to Week 16	No
Secondary	Change from baseline in Asthma Control Questionnaire (ACQ)	ACQ evaluates clinical impairment that participants with asthma may experience. Items are scored on a 7-point scale (0 = good control, 6 = poor control). Higher mean scores reflect poorer control.	Baseline to Week 16	No
Secondary	Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)	Expressed as percent of predicted value.	Baseline to Week 16	No
Secondary	Change from baseline in weekly average of daytime asthma diary symptom scores	Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.	Baseline to Week 16	No
Secondary	Change from baseline in weekly average of nighttime asthma diary symptom scores	Asthma diaries include questions about number of nocturnal awakenings.	Baseline to Week 16	No
Secondary	Change from baseline in weekly average of number of puffs in a day that rescue medication is used		Baseline to Week 16	No