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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00946569
First received: July 23, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: JNJ39758979
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent change from baseline in post-bronchodilator percent predicted Forced Vital Capacity (FVC) value [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value [ Time Frame: Week 4 and week 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to Week 12 in Asthma Daily Diary (ADD) data [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of participants with worsening of asthma [ Time Frame: From baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Time to worsening of asthma [ Time Frame: From baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
  • Plasma concentrations of JNJ-39758979 [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Plasma samples will be collected to measure pharmacokintetics of JNJ-39758979.

  • Serum concentrations of JNJ-39758979 [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Serum samples will be collected to measure various biomarkers (a substance used as an indicator of a biological state).

  • Number of participants with adverse events [ Time Frame: From screening (Week -6) to Week 17 ] [ Designated as safety issue: Yes ]

Enrollment: 116
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946569

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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00946569     History of Changes
Other Study ID Numbers: CR016423, 39758979ASH2001
Study First Received: July 23, 2009
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Asthma
Persistent asthma
Adults with persistent asthma
Chronic asthma
JNJ-39758979
Placebo

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014