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AsthmaPhase 2NCT00946569

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

A Phase 2 study testing JNJ39758979 in people with Asthma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 24 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
JNJ39758979
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
24 sitesin 4 countries
Study dates
Aug 2009to Sep 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

United States14 sites

  • Study site

    Cincinnati, Ohio

  • Study site

    Cypress, California

  • Study site

    Dallas, Texas

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Medford, Oregon

  • Study site

    Normal, Illinois

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Papillion, Nebraska

  • Study site

    Portland, Oregon

  • Study site

    San Diego, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Waco, Texas

Other trials in United States

Canada5 sites

  • Study site

    Kelowna, British Columbia

  • Study site

    Niagara Falls, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

India4 sites

  • Study site

    Chennai

  • Study site

    Mumbai

  • Study site

    Mysore

  • Study site

    Pune

Other trials in India

Romania1 site

  • Study site

    Bucharest

Other trials in Romania

About this study

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

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.

Read the 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.

Conditions
Asthma
Being tested
JNJ39758979, Placebo
Keywords
Asthma, Persistent asthma, Adults with persistent asthma, Chronic asthma, JNJ-39758979, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ39758979Drug

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

  • PlaceboDrug

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

Study groups in NCT00946569
Study groupRoleWhat they receive
Treatment A (JNJ39758979)ExperimentalParticipants will receive JNJ39758979 300mg once daily for 12 weeks.
Receives: Drug: JNJ39758979
Treatment B (Placebo)Placebo comparatorParticipants will receive matching placebo once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0) and Week 12

Secondary outcomes (14)

  1. Percent change from baseline 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.

    Measured: Week 1, Week 2, Week 4, and Week 8

  2. Percent change from baseline in post-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. Post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of 360 micrograms (4 puffs) of albuterol/salbutamol via metered-dose inhaler.

    Measured: Week 4 and Week 12

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

    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.

    Measured: Week 1, Week 2, Week 4, Week 8, and Week 12

  4. Percent change from baseline in post-bronchodilator percent predicted Forced Vital Capacity (FVC) value

    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.

    Measured: Week 4 and Week 12

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

    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.

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

  6. Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value

    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.

    Measured: Week 4 and week 12

  7. Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value

    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.

    Measured: Week 1, Week 2, Week 4, Week 8, and Week 12

  8. Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value

    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.

    Measured: Week 4 and Week 12

  9. Change from baseline to Week 12 in Asthma Daily Diary (ADD) data

    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.

    Measured: Week 12

  10. Number of participants with worsening of asthma

    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.

    Measured: From baseline (Week 0) to Week 12

  11. Time to worsening of asthma

    Measured: From baseline (Week 0) to Week 12

  12. Plasma concentrations of JNJ-39758979

    Plasma samples will be collected to measure pharmacokintetics of JNJ-39758979.

    Measured: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12

  13. Serum concentrations of JNJ-39758979

    Serum samples will be collected to measure various biomarkers (a substance used as an indicator of a biological state).

    Measured: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12

  14. Number of participants with adverse events

    Measured: From screening (Week -6) to Week 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00946569
Sponsor's protocol ID
CR016423
Other IDs
39758979ASH2001
Status last verified
Mar 2014
First submitted
23 Jul 2009
Last updated
29 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29682796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ39758979 in people with Asthma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 24 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, India, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00946569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.

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