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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADC3680
Placebo
montelukast
Sponsored by
Pulmagen Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
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  • Pulmagen Investigatinal Site
  • Pulmagen Investigational Site
  • Pulamgen Investigational Site
  • Pulmagen Investigational Site
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  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
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  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
  • Pulmagen Investigational Site
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  • Pulamgen Investigational Site
  • Pulmagen Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

ADC3680

Placebo

montelukast

Arm Description

ADC3680 oral once daily

Placebo oral once daily

montelukast oral once daily

Outcomes

Primary Outcome Measures

Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
Adding montelukast to ADC3680 in improving lung function (FEV1)

Secondary Outcome Measures

Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
Safety of ADC3680 compared to placebo
Safety evaluations will include incidence of Serious Adverse Events (from informed consent), severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from baseline to week 10.
Safety of a 2 week administration of ADC3680 in combination with montelukast
Safety evaluations will include incidence of Serious Adverse Events, severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from week 10 to week 12.

Full Information

First Posted
November 9, 2012
Last Updated
October 2, 2017
Sponsor
Pulmagen Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01730027
Brief Title
A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
Official Title
A Randomised, Double Blind, Placebo-Controlled, Multi-Centre, Parallel Group Study to 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 Subjects With Inadequately-Controlled Asthma.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmagen Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADC3680
Arm Type
Experimental
Arm Description
ADC3680 oral once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral once daily
Arm Title
montelukast
Arm Type
Active Comparator
Arm Description
montelukast oral once daily
Intervention Type
Drug
Intervention Name(s)
ADC3680
Intervention Description
ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Intervention Type
Drug
Intervention Name(s)
montelukast
Intervention Description
montelukast for 12 weeks
Primary Outcome Measure Information:
Title
Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
Time Frame
10 weeks
Title
Adding montelukast to ADC3680 in improving lung function (FEV1)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
Time Frame
10 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
Time Frame
2 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
Time Frame
6 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
Time Frame
10 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
Time Frame
10 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
Time Frame
2 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
Time Frame
6 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
Time Frame
10 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
Time Frame
10 weeks
Title
Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
Time Frame
10 weeks
Title
Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
Time Frame
2 weeks
Title
Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
Time Frame
2 weeks
Title
Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
Time Frame
2 weeks
Title
Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
Time Frame
2 weeks
Title
Safety of ADC3680 compared to placebo
Description
Safety evaluations will include incidence of Serious Adverse Events (from informed consent), severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from baseline to week 10.
Time Frame
10 weeks
Title
Safety of a 2 week administration of ADC3680 in combination with montelukast
Description
Safety evaluations will include incidence of Serious Adverse Events, severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from week 10 to week 12.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Pulmagen Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Pulmagen Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
922647
Country
United States
Facility Name
Pulmagen Investigational Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Pulmagen Investigational Site
City
Rolling Hills
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Pulmagen Investigational Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Pulmagen Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Pulmagen Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
6708
Country
United States
Facility Name
Pulmagen Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Pulmagen Investigational Site
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Pulmagen Investigational Site
City
Nottingham
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Pulmagen Investigational Site
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
Pulmagen Investigational Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Pulmagen Investigational Site
City
Bricktown
State/Province
New Jersey
Country
United States
Facility Name
Pulmagen Investigatinal Site
City
Clemmons
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Facility Name
Pulmagen Investigational Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Pulamgen Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Pulmagen Investigational Site
City
Maumee
State/Province
Ohio
Country
United States
Facility Name
Pulmagen Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Pulmagen Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Pulmagen Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Pulmagen Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pulmagen Investigational Site
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
Pulmagen Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Pulmagen Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Pulmagen Investigational Site
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Pulmagen Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Pulmagen Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pulmagen Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Pulmagen Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
Pulmagen Investigational Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Pulmagen Investgational Site
City
Woodway
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Pulmagen Investigational Site
City
Draper
State/Province
Utah
Country
United States
Facility Name
Pulmagen Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Pulmagen Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Pulmagen Investigational Site
City
Greenfield
State/Province
Wisconsin
Country
United States
Facility Name
Pulmagen Investigational Site
City
Cakovec
Country
Croatia
Facility Name
Pulmagen Investigational Site
City
Sisak
Country
Croatia
Facility Name
Pulmagen Investigational Site
City
Varazdin
Country
Croatia
Facility Name
Pulmagen Investigational Site
City
Zagreb
Country
Croatia
Facility Name
Pulmagen Investigational Site
City
Beroun
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Brno
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Havlickuv Brod
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Holesov
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Jaromer
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Neratovice
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Svitavy
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Teplice
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Tremosna
Country
Czechia
Facility Name
Pulmagen Investigational Site
City
Augsburg
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Bad Worishofen
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Berlin
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Bonn
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Deggingen
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Dresden
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Geesthacht
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Hagen
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Hamburg
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Hannover
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Marburg
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Schwerin
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Teuchem
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Weyhe
Country
Germany
Facility Name
Pulmagen Investigational Site
City
Balassagyarmat
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Budapest
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Kaposvar
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Komlo
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Pecs
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Szazhalombatta
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Szombathely
Country
Hungary
Facility Name
Pulmagen Investigational Site
City
Bialystok
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Bielsko Biala
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Bienkowka
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Kielce
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Krakow
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Lodz
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Olsztyn
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Ostrow Wilekopolski
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Poznan
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Proszowice
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Skierniewice
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Tarnow
Country
Poland
Facility Name
Pulamgen Investigational Site
City
Warszawa
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Wilkowice-Bystra
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Zabrze
Country
Poland
Facility Name
Pulmagen Investigational Site
City
Zgierz
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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