A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01823016
• Collaborator: (none)
• Enrollment: 166
• Locations: 54
• Arms: 2
• Duration (Months): 21.9
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Placebo; Drug: JNJ-38518168	Phase 2

Detailed Description

This study will be randomized (treatment group assigned by chance, like flipping a coin), double-blind (study investigators and participants will not know what treatment is being administered), and placebo-controlled (a placebo is identical to the study agent, but contains no active ingredients). A total of 160 participants will receive either placebo or JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. Participant safety will be monitored throughout the entire study period..

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet, taken once daily
Experimental: JNJ-38518168	Drug: JNJ-38518168; JNJ-38518168, 30 mg tablet, taken once daily

Outcome Measures

Primary Outcome Measures

1. Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1) [Baseline to Week 16]

   Expressed as percent of predicted value.

Secondary Outcome Measures

1. Change from baseline in Asthma Control Questionnaire (ACQ) [Baseline to Week 16]

   ACQ evaluates clinical impairment that participants with asthma may experience. Items are scored on a 7-point scale (0 = good control, 6 = poor control). Higher mean scores reflect poorer control.

2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1) [Baseline to Week 16]

   Expressed as percent of predicted value.

3. Change from baseline in weekly average of daytime asthma diary symptom scores [Baseline to Week 16]

   Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.

4. Change from baseline in weekly average of nighttime asthma diary symptom scores [Baseline to Week 16]

   Asthma diaries include questions about number of nocturnal awakenings.

5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used [Baseline to Week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1

• Have been receiving inhaled corticosteroid (ICS) (≤1000 µg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1

• At Screening Visit 1, be receiving the same dose of ICS ≤1000 µg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist (LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening

• Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1

• Have a prebronchodilator forced expiratory volume in 1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1

• Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2

Exclusion Criteria:

• Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma

• Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease

• Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1; cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks of Screening Visit 1; theophylline within 4 weeks of Screening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1

• Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1

• Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years

• Body-Mass Index (BMI) greater than or equal to 40 kg/m2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Scottsdale	Arizona	United States
2		Los Angeles	California	United States
3		Mission Viejo	California	United States
4		San Diego	California	United States
5		Denver	Colorado	United States
6		Waterbury	Connecticut	United States
7		Minneapolis	Minnesota	United States
8		St. Louis	Missouri	United States
9		Bellevue	Nebraska	United States
10		Lebanon	New Hampshire	United States
11		Rochester	New York	United States
12		Greenville	North Carolina	United States
13		Winston Salem	North Carolina	United States
14		Cincinnati	Ohio	United States
15		Cleveland	Ohio	United States
16		Medford	Oregon	United States
17		Portland	Oregon	United States
18		Altoona	Pennsylvania	United States
19		Dallas	Texas	United States
20		San Antonio	Texas	United States
21		Calgary	Alberta	Canada
22		Vancouver	British Columbia	Canada
23		Hamilton	Ontario	Canada
24		Kingston	Ontario	Canada
25		Ottawa	Ontario	Canada
26		Toronto	Ontario	Canada
27		Montreal	Quebec	Canada
28		Sainte Foy	Quebec	Canada
29		Quebec		Canada
30		Montpellier		France
31		Berlin		Germany
32		Frankfurt		Germany
33		Großhansdorf		Germany
34		Hannover		Germany
35		Koblenz		Germany
36		Leipzig		Germany
37		Lübeck		Germany
38		Magdeburg		Germany
39		Mainz		Germany
40		Rüdersdorf		Germany
41		Ashkelon		Israel
42		Haifa		Israel
43		Jerusalem		Israel
44		Ramat Gan		Israel
45		Rehovot		Israel
46		Tel Aviv		Israel
47		Chertsey		United Kingdom
48		Cottingham		United Kingdom
49		Dundee		United Kingdom
50		Glasgow		United Kingdom
51		London		United Kingdom
52		Portsmouth		United Kingdom
53		Southampton		United Kingdom
54		Wolverhampton		United Kingdom

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01823016
• Other Study ID Numbers: CR100976; 38518168ASH2001; 2012-004920-39
• First Posted: Apr 4, 2013
• Last Update Posted: Jun 2, 2016
• Last Verified: May 1, 2016

• Keywords provided by Janssen Research & Development, LLC: Uncontrolled, persistent asthma
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Jun 2, 2016