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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730027
• Other study ID #: ADC3680-07
• Secondary ID: 2012-003966-42
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2012
• Last updated: October 2, 2017
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2017
• Source: Pulmagen Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ADC3680
ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
• Placebo
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
• montelukast
montelukast for 12 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pulmagen Therapeutics

Countries where clinical trial is conducted

United States,  Croatia,  Czechia,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)		10 weeks
Primary	Adding montelukast to ADC3680 in improving lung function (FEV1)		2 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10		10 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2		2 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6		6 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10		10 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10		10 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2		2 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6		6 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10		10 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10		10 weeks
Secondary	Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10		10 weeks
Secondary	Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12		2 weeks
Secondary	Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12		2 weeks
Secondary	Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12		2 weeks
Secondary	Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12		2 weeks
Secondary	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.	10 weeks
Secondary	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.	2 weeks