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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAsthma
InterventionDrug: ADC3680
Drug: Placebo
Drug: montelukast
PhasePhase 2
SponsorPulmagen Therapeutics
Responsible PartyPulmagen Therapeutics
ClinicalTrials.gov IdentifierNCT01730027
First ReceivedNovember 9, 2012
Last UpdatedMarch 21, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateNovember 9, 2012
Last Updated DateMarch 21, 2014
Start DateApril 2013
Estimated Primary Completion DateNovember 2014
Current Primary Outcome Measures
  • Efficacy of ADC3680 compared with placebo in improving lung function (FEV1) [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Adding montelukast to ADC3680 in improving lung function (FEV1) [Time Frame: 2 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6 [Time Frame: 6 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6 [Time Frame: 6 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10 [Time Frame: 10 weeks] [Designated as safety issue: No]
  • Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12 [Time Frame: 2 weeks] [Designated as safety issue: No]
  • Safety of ADC3680 compared to placebo [Time Frame: 10 weeks] [Designated as safety issue: Yes]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 [Time Frame: 2 weeks] [Designated as safety issue: Yes]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.

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
Official TitleA 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.
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.
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionAsthma
InterventionDrug: ADC3680
ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Drug: Placebo
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Drug: montelukast
montelukast for 12 weeks
Study Arm (s)
  • Experimental: ADC3680
    ADC3680 oral once daily
  • Placebo Comparator: Placebo
    Placebo oral once daily
  • Active Comparator: montelukast
    montelukast oral once daily

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment330
Estimated Completion DateNovember 2014
Estimated Primary Completion DateJune 2014
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Mary Fitzgerald
info@pulmagen.com
Location CountriesUnited States, Croatia, Czech Republic, Germany, Hungary, Poland

Administrative Information[ + expand ][ + ]

NCT Number NCT01730027
Other Study ID NumbersADC3680-07
Has Data Monitoring CommitteeNo
Information Provided ByPulmagen Therapeutics
Study SponsorPulmagen Therapeutics
CollaboratorsNot Provided
Investigators Not Provided
Verification DateMarch 2014

Locations[ + expand ][ + ]

Pulmagen Investigational Site
Birmingham, Alabama, United States
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Huntington Beach, California, United States, 922647
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Riverside, California, United States
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Rolling Hill, California, United States, 90274
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San Jose, California, United States
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Colorado Springs, Colorado, United States
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Waterbury, Connecticut, United States, 6708
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Lawrenceville, Georgia, United States, 30046
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Eagle, Idaho, United States, 83616
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Nottingham, Maryland, United States, 21236
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Plymouth, Minnesota, United States
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Bellevue, Nebraska, United States, 68123
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Brick, New Jersey, United States
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Clemmos, North Carolina, United States, 27012
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Canton, Ohio, United States
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Cincinnati, Ohio, United States, 45231
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Maumee, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States, 74136
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Medford, Oregon, United States
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Portland, Oregon, United States
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East Providence, Rhode Island, United States
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Warwick, Rhode Island, United States, 02886
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Charleston, South Carolina, United States
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Fort Mill, South Carolina, United States, 29707
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Arlington, Texas, United States
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Austin, Texas, United States
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Houston, Texas, United States, 77099
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Killeen, Texas, United States
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Waco, Texas, United States
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Woodway, Texas, United States, 76712
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Draper, Utah, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States, 98405
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Greenfield, Wisconsin, United States
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Cakovec, Croatia
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Sisak, Croatia
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Varazdin, Croatia
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Zagreb, Croatia
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Beroun, Czech Republic
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Brno, Czech Republic
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Havlickuv Brod, Czech Republic
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Holesov, Czech Republic
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Jaromer, Czech Republic
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Neratovice, Czech Republic
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Svitavy, Czech Republic
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Teplice, Czech Republic
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Tremosna, Czech Republic
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Augsburg, Germany
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Bad Worishofen, Germany
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Berlin, Germany
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Bonn, Germany
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Deggingen, Germany
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Dresden, Germany
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Geesthacht, Germany
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Hagen, Germany
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Hamburg, Germany
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Hannover, Germany
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Marburg, Germany
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Schwerin, Germany
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Teuchem, Germany
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Weyhe, Germany
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Balassagyarmat, Hungary
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Budapest, Hungary
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Kaposvar, Hungary
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Komlo, Hungary
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Pecs, Hungary
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Szazhalombatta, Hungary
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Szombathely, Hungary
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Bialystok, Poland
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Bielsko Biala, Poland
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Bienkowka, Poland
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Bydgoszcz, Poland
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Kielce, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Ostrow Wilekopolski, Poland
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Poznan, Poland
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Proszowice, Poland
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Skierniewice, Poland
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Tarnow, Poland
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Warszawa, Poland
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Wilkowice-Bystra, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Zgierz, Poland
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