A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

March 31, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Ontario
      • Niagara Falls, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
  • India
      • Chennai, India
      • Mumbai, India
      • Mysore, India
      • Pune, India
  • Romania
      • Bucuresti, Romania
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Cypress, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
    • Illinois
      • Normal, Illinois, United States
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
    • Nebraska
      • Papillion, Nebraska, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Texas
      • Dallas, Texas, United States
      • Waco, Texas, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of asthma for at least 6 months
  • Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
  • Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
  • Having adequate laboratory values
  • No history of/active or latent tuberculosis
  • Agree to use protocol defined contraceptive methods

Exclusion Criteria:

  • History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
  • Moderate or severe renal insufficiency
  • Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
  • Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A (JNJ39758979)
Participants will receive JNJ39758979 300mg once daily for 12 weeks.
Drug: JNJ39758979
Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.
Placebo Comparator: Treatment B (Placebo)
Participants will receive matching placebo once daily for 12 weeks.
Drug: Placebo
Participants will receive matching placebo once daily orally for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Time Frame: Baseline (Week 0) and Week 12
FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
Baseline (Week 0) and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Time Frame: Week 1, Week 2, Week 4, and Week 8
FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
Week 1, Week 2, Week 4, and Week 8
Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
Time Frame: Week 4 and Week 12
FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of 360 micrograms (4 puffs) of albuterol/salbutamol via metered-dose inhaler.
Week 4 and Week 12
Percent change from baseline in pre-bronchodilator percent predicted Forced Vital Capacity (FVC) value
Time Frame: Week 1, Week 2, Week 4, Week 8, and Week 12
FVC will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FVC is the volume of air that can forcibly be blown out after full inspiration and is measured in liters. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
Week 1, Week 2, Week 4, Week 8, and Week 12
Percent change from baseline in post-bronchodilator percent predicted Forced Vital Capacity (FVC) value
Time Frame: Week 4 and Week 12
FVC will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FVC is the volume of air that can forcibly be blown out after full inspiration and is measured in liters. Post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of 360 micrograms (4 puffs) of albuterol/salbutamol via metered-dose inhaler.
Week 4 and Week 12
Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value
Time Frame: Week 1, Week 2, week 4, Week 8, and Week 12
FEF will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FEF is the speed (or flow) of air coming out of the lung during the middle portion of a forced expiration. It is generally defined by what fraction remains of the forced vital capacity (FVC), usually 25-75 percent (FEF25-75%). Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
Week 1, Week 2, week 4, Week 8, and Week 12
Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value
Time Frame: Week 4 and week 12
FEF will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FEF is the speed (or flow) of air coming out of the lung during the middle portion of a forced expiration. It is generally defined by what fraction remains of the forced vital capacity (FVC), usually 25-75 percent (FEF25-75%). Post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of 360 micrograms (4 puffs) of albuterol/salbutamol via metered-dose inhaler.
Week 4 and week 12
Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value
Time Frame: Week 1, Week 2, Week 4, Week 8, and Week 12
FEV1/FVC is the ratio of FEV1 to FVC and will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and FVC is the volume of air that can forcibly be blown out after full inspiration. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
Week 1, Week 2, Week 4, Week 8, and Week 12
Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value
Time Frame: Week 4 and Week 12
FEV1/FVC is the ratio of FEV1 to FVC and will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and FVC is the volume of air that can forcibly be blown out after full inspiration. Post bronchodilator spirometry will be performed after 15 - to 30 minutes administration of 360 micrograms (4 puffs) of albuterol/salbutamol via metered-dose inhaler.
Week 4 and Week 12
Change from baseline to Week 12 in Asthma Daily Diary (ADD) data
Time Frame: Week 12
ADD is an electronic peak flow/diary device to score asthma symptoms twice daily (12 hours interval). Upon awakening, participants are asked to record 3 peak expiratory flow rates (PEFR), number of puffs of albuterol/salbutamol in the past 24 hours and indicate whether they had night time awakenings requiring albuterol/salbutamol. In the evening, participants are asked to record 3 PEFRs and rate asthma symptoms using a 6-point scale (0 = No symptoms and 5 = symptoms so severe that I could not go to work or perform normal daily activities). Higher scores indicate worsening.
Week 12
Number of participants with worsening of asthma
Time Frame: From baseline (Week 0) to Week 12
Worsening of asthma is defined as any episode of: 1) decrease in Forced Expiratory Volume in 1 second (FEV1) of greater than or equal to 20 percent compared to baseline FEV1, 2) requiring treatment with systemic corticosteroids, 3) requiring treatment with any other prohibited asthma medication including inhaled corticosteroids, 4) requires emergency room treatment or hospitalization, and 5) life-threatening asthma attack that requires intubation or intensive care unit admission.
From baseline (Week 0) to Week 12
Time to worsening of asthma
Time Frame: From baseline (Week 0) to Week 12
From baseline (Week 0) to Week 12
Plasma concentrations of JNJ-39758979
Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
Plasma samples will be collected to measure pharmacokintetics of JNJ-39758979.
Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
Serum concentrations of JNJ-39758979
Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
Serum samples will be collected to measure various biomarkers (a substance used as an indicator of a biological state).
Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
Number of participants with adverse events
Time Frame: From screening (Week -6) to Week 17
From screening (Week -6) to Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016423
  • 39758979ASH2001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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