MedDataX Logo

A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma

NCT ID: NCT01730027

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when co-administered with montelukast in patients with inadequately-controlled asthma. Patients will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-centre, randomised, placebo-controlled, double blind, parallel group 3-arm study (including montelukast as an active comparator) designed to compare the efficacy and safety of a once daily dose of ADC3680 with placebo in subjects with inadequately-controlled asthma despite receiving a low to moderate dose of an ICS controller therapy, over a 10 week treatment period. At the end of the 10 week treatment period open label montelukast (10 mg) will be added to ADC3680 and placebo arms for a two week extension period to assess whether efficacy of ADC3680 is enhanced by the addition of montelukast compared with montelukast alone. The montelukast arm will continue with 10 mg montelukast alone.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADC3680

ADC3680 oral once daily

Group Type EXPERIMENTAL

ADC3680

Intervention Type DRUG

ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period

Placebo

Placebo oral once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period

montelukast

montelukast oral once daily

Group Type ACTIVE_COMPARATOR

montelukast

Intervention Type DRUG

montelukast for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADC3680

ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period

Intervention Type DRUG

Placebo

Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period

Intervention Type DRUG

montelukast

montelukast for 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women aged 18 years to 50 years (inclusive)
* Diagnosis of asthma (GINA 2011) including a demonstration of reversible airway obstruction
* Pre-bronchodilator FEV1 value ≥ 40% and ≤ 85% of the predicted normal value at baseline
* A score of 1.5 or greater on the Asthma Control Questionnaire at baseline
* Daily use of low to moderate dose of ICS (equivalent to budesonide ≤ 800 µg per day)
* Prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of symptoms
* A peripheral blood eosinophil count ≥ 0.25 x 109/L
* Non-smoker or former smoker who has not smoked in the last six months
* Body mass index (BMI) ≥ 17 and ≤ 35 kg/m2
* Able to comply with the protocol requirements, instructions and restrictions
* Able to provide signed and dated written informed consent

Exclusion Criteria

* Subjects with severe asthma exacerbation in the 4 weeks prior to consent
* Subjects with respiratory tract infection in the 4 weeks prior to consent
* Subjects with COPD or other relevant lung diseases
* Subjects with clinically significant condition which may compromise subject safety or interfere with study evaluation
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pulmagen Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pulmagen Investigational Site

Birmingham, Alabama, United States

Site Status

Pulmagen Investigational Site

Huntington Beach, California, United States

Site Status

Pulmagen Investigational Site

Riverside, California, United States

Site Status

Pulmagen Investigational Site

Rolling Hills, California, United States

Site Status

Pulmagen Investigational Site

San Jose, California, United States

Site Status

Pulmagen Investigational Site

Colorado Springs, Colorado, United States

Site Status

Pulmagen Investigational Site

Waterbury, Connecticut, United States

Site Status

Pulmagen Investigational Site

Lawrenceville, Georgia, United States

Site Status

Pulmagen Investigational Site

Eagle, Idaho, United States

Site Status

Pulmagen Investigational Site

Nottingham, Maryland, United States

Site Status

Pulmagen Investigational Site

Plymouth, Minnesota, United States

Site Status

Pulmagen Investigational Site

Bellevue, Nebraska, United States

Site Status

Pulmagen Investigational Site

Brick, New Jersey, United States

Site Status

Pulmagen Investigatinal Site

Clemmons, North Carolina, United States

Site Status

Pulmagen Investigational Site

Canton, Ohio, United States

Site Status

Pulamgen Investigational Site

Cincinnati, Ohio, United States

Site Status

Pulmagen Investigational Site

Maumee, Ohio, United States

Site Status

Pulmagen Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pulmagen Investigational Site

Tulsa, Oklahoma, United States

Site Status

Pulmagen Investigational Site

Medford, Oregon, United States

Site Status

Pulmagen Investigational Site

Portland, Oregon, United States

Site Status

Pulmagen Investigational Site

East Providence, Rhode Island, United States

Site Status

Pulmagen Investigational Site

Warwick, Rhode Island, United States

Site Status

Pulmagen Investigational Site

Charleston, South Carolina, United States

Site Status

Pulmagen Investigational Site

Fort Mill, South Carolina, United States

Site Status

Pulmagen Investigational Site

Arlington, Texas, United States

Site Status

Pulmagen Investigational Site

Austin, Texas, United States

Site Status

Pulmagen Investigational Site

Houston, Texas, United States

Site Status

Pulmagen Investigational Site

Killeen, Texas, United States

Site Status

Pulmagen Investigational Site

Waco, Texas, United States

Site Status

Pulmagen Investgational Site

Woodway, Texas, United States

Site Status

Pulmagen Investigational Site

Draper, Utah, United States

Site Status

Pulmagen Investigational Site

Seattle, Washington, United States

Site Status

Pulmagen Investigational Site

Tacoma, Washington, United States

Site Status

Pulmagen Investigational Site

Greenfield, Wisconsin, United States

Site Status

Pulmagen Investigational Site

Čakovec, , Croatia

Site Status

Pulmagen Investigational Site

Sisak, , Croatia

Site Status

Pulmagen Investigational Site

Varaždin, , Croatia

Site Status

Pulmagen Investigational Site

Zagreb, , Croatia

Site Status

Pulmagen Investigational Site

Beroun, , Czechia

Site Status

Pulmagen Investigational Site

Brno, , Czechia

Site Status

Pulmagen Investigational Site

Havlíčkův Brod, , Czechia

Site Status

Pulmagen Investigational Site

Holešov, , Czechia

Site Status

Pulmagen Investigational Site

Jaroměř, , Czechia

Site Status

Pulmagen Investigational Site

Neratovice, , Czechia

Site Status

Pulmagen Investigational Site

Svitavy, , Czechia

Site Status

Pulmagen Investigational Site

Teplice, , Czechia

Site Status

Pulmagen Investigational Site

Třemošná, , Czechia

Site Status

Pulmagen Investigational Site

Augsburg, , Germany

Site Status

Pulmagen Investigational Site

Bad Wörishofen, , Germany

Site Status

Pulmagen Investigational Site

Berlin, , Germany

Site Status

Pulmagen Investigational Site

Bonn, , Germany

Site Status

Pulmagen Investigational Site

Deggingen, , Germany

Site Status

Pulmagen Investigational Site

Dresden, , Germany

Site Status

Pulmagen Investigational Site

Geesthacht, , Germany

Site Status

Pulmagen Investigational Site

Hagen, , Germany

Site Status

Pulmagen Investigational Site

Hamburg, , Germany

Site Status

Pulmagen Investigational Site

Hanover, , Germany

Site Status

Pulmagen Investigational Site

Marburg, , Germany

Site Status

Pulmagen Investigational Site

Schwerin, , Germany

Site Status

Pulmagen Investigational Site

Teuchem, , Germany

Site Status

Pulmagen Investigational Site

Weyhe, , Germany

Site Status

Pulmagen Investigational Site

Balassagyarmat, , Hungary

Site Status

Pulmagen Investigational Site

Budapest, , Hungary

Site Status

Pulmagen Investigational Site

Kaposvár, , Hungary

Site Status

Pulmagen Investigational Site

Komló, , Hungary

Site Status

Pulmagen Investigational Site

Pécs, , Hungary

Site Status

Pulmagen Investigational Site

Százhalombatta, , Hungary

Site Status

Pulmagen Investigational Site

Szombathely, , Hungary

Site Status

Pulmagen Investigational Site

Bialystok, , Poland

Site Status

Pulmagen Investigational Site

Bielsko-Biala, , Poland

Site Status

Pulmagen Investigational Site

Bieńkówka, , Poland

Site Status

Pulmagen Investigational Site

Bydgoszcz, , Poland

Site Status

Pulmagen Investigational Site

Kielce, , Poland

Site Status

Pulmagen Investigational Site

Krakow, , Poland

Site Status

Pulmagen Investigational Site

Lodz, , Poland

Site Status

Pulmagen Investigational Site

Olsztyn, , Poland

Site Status

Pulmagen Investigational Site

Ostrow Wilekopolski, , Poland

Site Status

Pulmagen Investigational Site

Poznan, , Poland

Site Status

Pulmagen Investigational Site

Proszowice, , Poland

Site Status

Pulmagen Investigational Site

Skierniewice, , Poland

Site Status

Pulmagen Investigational Site

Tarnów, , Poland

Site Status

Pulamgen Investigational Site

Warsaw, , Poland

Site Status

Pulmagen Investigational Site

Wilkowice-Bystra, , Poland

Site Status

Pulmagen Investigational Site

Wroclaw, , Poland

Site Status

Pulmagen Investigational Site

Zabrze, , Poland

Site Status

Pulmagen Investigational Site

Zgierz, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Croatia Czechia Germany Hungary Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-003966-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ADC3680-07

Identifier Type: -

Identifier Source: org_study_id