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

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.

Condition	Intervention	Phase
Asthma	Drug: ADC3680 Drug: Placebo Drug: montelukast	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Pulmagen Therapeutics:

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 ]

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.

Estimated Enrollment:	330
Study Start Date:	April 2013
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ADC3680 ADC3680 oral once daily	Drug: ADC3680 ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Placebo Comparator: Placebo Placebo oral once daily	Drug: Placebo Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Active Comparator: montelukast montelukast oral once daily	Drug: montelukast montelukast for 12 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730027

Contacts

Contact: Mary Fitzgerald

info@pulmagen.com

Locations

United States, Colorado
Pulmagen Investigational Site	Recruiting
Colorado Springs, Colorado, United States

Sponsors and Collaborators

Pulmagen Therapeutics

More Information

No publications provided

Responsible Party:	Pulmagen Therapeutics
ClinicalTrials.gov Identifier:	NCT01730027 History of Changes
Other Study ID Numbers:	ADC3680-07, 2012-003966-42
Study First Received:	November 9, 2012
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013