AsthmaPhase 2NCT00530166
Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.
A Phase 2 study testing JNJ-18054478 in people with Asthma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 36 sites in 3 countries.
Trial summary
The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients 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?
- JNJ-18054478
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 36 sitesin 3 countries
- Study dates
- Jul 2007to Jul 2008
- 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
- Medically confirmed diagnosis of persistent asthma
- Able to demonstrate reversibility of at least 12% with albuterol inhalation
- Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
- Able to produce an FEV1 between 45 and 85% of predicted
- Willing to perform study procedures for about 14 weeks.
Who cannot join
- Use of inhaled corticosteroids within 4 weeks
- Use of oral/parenteral corticosteroids within 8 weeks
- Use of long-acting beta-2 agonists or montelukast within 2 weeks
- History of life-threatening asthma attack within 3 months
- Female of child bearing potential.
Trial locations and contacts
36 sites in 3 countries.
36 sites in 3 countries
United States29 sites
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Canton, Ohio
Study site
Chester, Pennsylvania
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Colorado Springs, Colorado
Study site
Dallas, Texas
Study site
Lake Oswego, Oregon
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Medford, Oregon
Study site
Normal, Illinois
Study site
North Dartmouth, Massachusetts
Study site
North Syracuse, New York
Study site
Oklahoma City, Oklahoma
Study site
Paramount, California
Study site
Philadelphia, Pennsylvania
Study site
Plymouth, Minnesota
Study site
Portland, Oregon
Study site
Pueblo, Colorado
Study site
River Forest, Illinois
Study site
Rochester, New York
Study site
San Jose, California
Study site
Scottsdale, Arizona
Study site
Skillman, New Jersey
Study site
St Louis, Missouri
Study site
Tulsa, Oklahoma
India6 sites
Study site
Bangalore
Study site
Chennai
Study site
Hyderabad
Study site
Mumbai
Study site
Mysore
Study site
Vellore
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma
The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.
Read the detailed description
Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.
- Conditions
- Asthma
- Being tested
- JNJ-18054478, sham comparator
- Keywords
- Asthma, persistant asthma, controller medications, FEV1
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-18054478Drug
3(100 mg) tablets once daily for 12 weeks
sham comparatorDrug
3(100 mg) tablets once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 002 | Experimental | sham comparator 3(100 mg) tablets once daily for 12 weeks Receives: Drug: sham comparator |
| 001 | Experimental | JNJ-18054478 3(100 mg) tablets once daily for 12 weeks Receives: Drug: JNJ-18054478 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
Measured: 12 weeks
Secondary outcomes (1)
The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Lack of efficacy following an interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530166
- Sponsor's protocol ID
- CR013087
- Other IDs
- 18054478NAP2002
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2007
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00530166
- Acronym / sponsor ID
- CR013087
- Conditions
- Asthma
- Keywords
- Asthma, persistant asthma, controller medications, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy following an interim analysis
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.
Detailed description
Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 002 | Experimental | Drug: sham comparatorsham comparator 3(100 mg) tablets once daily for 12 weeks |
| 001 | Experimental | Drug: JNJ-18054478JNJ-18054478 3(100 mg) tablets once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically confirmed diagnosis of persistent asthma
- Able to demonstrate reversibility of at least 12% with albuterol inhalation
- Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
- Able to produce an FEV1 between 45 and 85% of predicted
- Willing to perform study procedures for about 14 weeks.
Key exclusion criteria (5 listed)
- Use of inhaled corticosteroids within 4 weeks
- Use of oral/parenteral corticosteroids within 8 weeks
- Use of long-acting beta-2 agonists or montelukast within 2 weeks
- History of life-threatening asthma attack within 3 months
- Female of child bearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-180544783(100 mg) tablets once daily for 12 weeks | Drug | 001 |
| sham comparator3(100 mg) tablets once daily for 12 weeks | Drug | 002 |
Primary outcome
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
Time frame: 12 weeks
1 secondary outcome
The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of efficacy following an interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
36 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-18054478 in people with Asthma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 36 sites in 3 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, India, Costa Rica. 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. 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 was stopped early (reason given: Lack of efficacy following an interim analysis). Results are not available in the source record.
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?
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2014.