NCT00946569

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Aug 2009

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 29, 2014

Status Verified

March 1, 2014

Enrollment Period

1.1 years

First QC Date

July 23, 2009

Last Update Submit

March 31, 2014

Conditions

Asthma

Keywords

AsthmaPersistent asthmaAdults with persistent asthmaChronic asthmaJNJ-39758979Placebo

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value

    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 Outcomes (14)

  • Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value

    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

    Week 4 and Week 12

  • Percent change from baseline in pre-bronchodilator percent predicted Forced Vital Capacity (FVC) value

    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

    Week 4 and Week 12

  • Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value

    Week 1, Week 2, week 4, Week 8, and Week 12

  • +9 more secondary outcomes

Study Arms (2)

Treatment A (JNJ39758979)

EXPERIMENTAL

Participants will receive JNJ39758979 300mg once daily for 12 weeks.

Drug: JNJ39758979

Treatment B (Placebo)

PLACEBO COMPARATOR

Participants will receive matching placebo once daily for 12 weeks.

Drug: Placebo

Interventions

JNJ39758979DRUG

Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.

Treatment A (JNJ39758979)
PlaceboDRUG

Participants will receive matching placebo once daily orally for 12 weeks.

Treatment B (Placebo)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Cypress, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Normal, Illinois, United States

Location

Unknown Facility

North Dartmouth, Massachusetts, United States

Location

Unknown Facility

Papillion, Nebraska, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Waco, Texas, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Kelowna, British Columbia, Canada

Location

Unknown Facility

Niagara Falls, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Chennai, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

Mysore, India

Location

Unknown Facility

Pune, India

Location

Unknown Facility

Bucharest, Romania

Location

Related Publications (1)

  • Kollmeier AP, Greenspan A, Xu XL, Silkoff PE, Barnathan ES, Loza MJ, Jiang J, Zhou B, Chen B, Thurmond RL. Phase 2a, randomized, double-blind, placebo-controlled, multicentre, parallel-group study of an H4 R-antagonist (JNJ-39758979) in adults with uncontrolled asthma. Clin Exp Allergy. 2018 Aug;48(8):957-969. doi: 10.1111/cea.13154. Epub 2018 Jun 6.

    PMID: 29682796DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 29, 2014

Record last verified: 2014-03

Locations

IN(4)CA(5)RO(1)US(14)