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

NCT01730027 | Completed Phase 2

• 2 other identifiers: ADC3680-072012-003966-42
• Study Type: interventional
• Target: 248
• Locations: 6 countries
• Sites: 87

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)

  10 weeks

• Adding montelukast to ADC3680 in improving lung function (FEV1)

  2 weeks

Secondary Outcomes (16)

• Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10

  10 weeks

• Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2

  2 weeks

• Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6

  6 weeks

• Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10

  10 weeks

• Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10

  10 weeks

Study Arms (3)

ADC3680

EXPERIMENTAL

ADC3680 oral once daily

Drug: ADC3680

Placebo

PLACEBO COMPARATOR

Placebo oral once daily

Drug: Placebo

montelukast

ACTIVE COMPARATOR

montelukast oral once daily

Drug: montelukast

Interventions

ADC3680 DRUG

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

ADC3680

Placebo DRUG

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

Placebo

montelukast DRUG

montelukast for 12 weeks

montelukast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmagen Therapeutics: lead

Study Sites (87)

Pulmagen Investigational Site

Birmingham, Alabama, United States

Location

Pulmagen Investigational Site

Huntington Beach, California, 922647, United States

Location

Pulmagen Investigational Site

Riverside, California, United States

Location

Pulmagen Investigational Site

Rolling Hills, California, 90274, United States

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Pulmagen Investigational Site

San Jose, California, United States

Location

Pulmagen Investigational Site

Colorado Springs, Colorado, United States

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Pulmagen Investigational Site

Waterbury, Connecticut, 6708, United States

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Pulmagen Investigational Site

Lawrenceville, Georgia, 30046, United States

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Pulmagen Investigational Site

Eagle, Idaho, 83616, United States

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Pulmagen Investigational Site

Nottingham, Maryland, 21236, United States

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Pulmagen Investigational Site

Plymouth, Minnesota, United States

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Pulmagen Investigational Site

Bellevue, Nebraska, 68123, United States

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Pulmagen Investigational Site

Brick, New Jersey, United States

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Pulmagen Investigatinal Site

Clemmons, North Carolina, 27012, United States

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Pulmagen Investigational Site

Canton, Ohio, United States

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Pulamgen Investigational Site

Cincinnati, Ohio, 45231, United States

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Pulmagen Investigational Site

Maumee, Ohio, United States

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Pulmagen Investigational Site

Oklahoma City, Oklahoma, United States

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Pulmagen Investigational Site

Tulsa, Oklahoma, 74136, United States

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Pulmagen Investigational Site

Medford, Oregon, United States

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Pulmagen Investigational Site

Portland, Oregon, United States

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Pulmagen Investigational Site

East Providence, Rhode Island, United States

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Pulmagen Investigational Site

Warwick, Rhode Island, 02886, United States

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Pulmagen Investigational Site

Charleston, South Carolina, United States

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Pulmagen Investigational Site

Fort Mill, South Carolina, 29707, United States

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Pulmagen Investigational Site

Arlington, Texas, United States

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Pulmagen Investigational Site

Austin, Texas, United States

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Pulmagen Investigational Site

Houston, Texas, 77099, United States

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Pulmagen Investigational Site

Killeen, Texas, United States

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Pulmagen Investigational Site

Waco, Texas, United States

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Pulmagen Investgational Site

Woodway, Texas, 76712, United States

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Pulmagen Investigational Site

Draper, Utah, United States

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Pulmagen Investigational Site

Seattle, Washington, United States

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Pulmagen Investigational Site

Tacoma, Washington, 98405, United States

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Pulmagen Investigational Site

Greenfield, Wisconsin, United States

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Pulmagen Investigational Site

Čakovec, Croatia

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Sisak, Croatia

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Pulmagen Investigational Site

Varaždin, Croatia

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Zagreb, Croatia

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Pulmagen Investigational Site

Beroun, Czechia

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Pulmagen Investigational Site

Brno, Czechia

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Pulmagen Investigational Site

Havlíčkův Brod, Czechia

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Pulmagen Investigational Site

Holešov, Czechia

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Pulmagen Investigational Site

Jaroměř, Czechia

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Pulmagen Investigational Site

Neratovice, Czechia

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Pulmagen Investigational Site

Svitavy, Czechia

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Pulmagen Investigational Site

Teplice, Czechia

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Pulmagen Investigational Site

Třemošná, Czechia

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Pulmagen Investigational Site

Augsburg, Germany

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Pulmagen Investigational Site

Bad Wörishofen, Germany

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Pulmagen Investigational Site

Berlin, Germany

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Pulmagen Investigational Site

Bonn, Germany

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Pulmagen Investigational Site

Deggingen, Germany

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Pulmagen Investigational Site

Dresden, Germany

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Pulmagen Investigational Site

Geesthacht, Germany

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Pulmagen Investigational Site

Hagen, Germany

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Pulmagen Investigational Site

Hamburg, Germany

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Pulmagen Investigational Site

Hanover, Germany

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Pulmagen Investigational Site

Marburg, Germany

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Pulmagen Investigational Site

Schwerin, Germany

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Pulmagen Investigational Site

Teuchem, Germany

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Pulmagen Investigational Site

Weyhe, Germany

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Pulmagen Investigational Site

Balassagyarmat, Hungary

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Pulmagen Investigational Site

Budapest, Hungary

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Pulmagen Investigational Site

Kaposvár, Hungary

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Pulmagen Investigational Site

Komló, Hungary

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Pulmagen Investigational Site

Pécs, Hungary

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Pulmagen Investigational Site

Százhalombatta, Hungary

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Szombathely, Hungary

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Pulmagen Investigational Site

Bialystok, Poland

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Pulmagen Investigational Site

Bielsko-Biala, Poland

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Pulmagen Investigational Site

Bieńkówka, Poland

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Pulmagen Investigational Site

Bydgoszcz, Poland

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Pulmagen Investigational Site

Kielce, Poland

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Pulmagen Investigational Site

Krakow, Poland

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Pulmagen Investigational Site

Lodz, Poland

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Pulmagen Investigational Site

Olsztyn, Poland

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Pulmagen Investigational Site

Ostrow Wilekopolski, Poland

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Pulmagen Investigational Site

Poznan, Poland

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Pulmagen Investigational Site

Proszowice, Poland

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Pulmagen Investigational Site

Skierniewice, Poland

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Pulmagen Investigational Site

Tarnów, Poland

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Pulamgen Investigational Site

Warsaw, Poland

Location

Pulmagen Investigational Site

Wilkowice-Bystra, Poland

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Pulmagen Investigational Site

Wroclaw, Poland

Location

Pulmagen Investigational Site

Zabrze, Poland

Location

Pulmagen Investigational Site

Zgierz, Poland

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 21, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (35); DE (14); HU (7); CZ (9); CR (4); PL (18)