AsthmaPhase 2NCT01730027

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

A Phase 2 study testing ADC3680 and montelukast in people with Asthma, run by Pulmagen Therapeutics at 87 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Asthma
What is being tested?: ADC3680 and montelukast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 248 participants
Where: 87 sitesin 6 countries
Study dates: Apr 2013to Dec 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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.

Trial locations and contacts

87 sites in 6 countries.

Country

City, postcode or hospital

87 sites in 6 countries

United States35 sites

Pulmagen Investigational Site
Arlington, Texas
Pulmagen Investigational Site
Austin, Texas
Pulmagen Investigational Site
Bellevue, Nebraska, 68123
Pulmagen Investigational Site
Birmingham, Alabama
Pulmagen Investigational Site
Brick, New Jersey
Pulmagen Investigational Site
Canton, Ohio
Pulmagen Investigational Site
Charleston, South Carolina
Pulamgen Investigational Site
Cincinnati, Ohio, 45231
Pulmagen Investigatinal Site
Clemmons, North Carolina, 27012
Pulmagen Investigational Site
Colorado Springs, Colorado
Pulmagen Investigational Site
Draper, Utah
Pulmagen Investigational Site
Eagle, Idaho, 83616
Pulmagen Investigational Site
East Providence, Rhode Island
Pulmagen Investigational Site
Fort Mill, South Carolina, 29707
Pulmagen Investigational Site
Greenfield, Wisconsin
Pulmagen Investigational Site
Houston, Texas, 77099
Pulmagen Investigational Site
Huntington Beach, California, 922647
Pulmagen Investigational Site
Killeen, Texas
Pulmagen Investigational Site
Lawrenceville, Georgia, 30046
Pulmagen Investigational Site
Maumee, Ohio
Pulmagen Investigational Site
Medford, Oregon
Pulmagen Investigational Site
Nottingham, Maryland, 21236
Pulmagen Investigational Site
Oklahoma City, Oklahoma
Pulmagen Investigational Site
Plymouth, Minnesota
Pulmagen Investigational Site
Portland, Oregon
Pulmagen Investigational Site
Riverside, California
Pulmagen Investigational Site
Rolling Hills, California, 90274
Pulmagen Investigational Site
San Jose, California
Pulmagen Investigational Site
Seattle, Washington
Pulmagen Investigational Site
Tacoma, Washington, 98405
Pulmagen Investigational Site
Tulsa, Oklahoma, 74136
Pulmagen Investigational Site
Waco, Texas
Pulmagen Investigational Site
Warwick, Rhode Island, 02886
Pulmagen Investigational Site
Waterbury, Connecticut, 6708
Pulmagen Investgational Site
Woodway, Texas, 76712

Other trials in United States

Poland18 sites

Pulmagen Investigational Site
Bialystok
Pulmagen Investigational Site
Bielsko-Biala
Pulmagen Investigational Site
Bieńkówka
Pulmagen Investigational Site
Bydgoszcz
Pulmagen Investigational Site
Kielce
Pulmagen Investigational Site
Krakow
Pulmagen Investigational Site
Lodz
Pulmagen Investigational Site
Olsztyn
Pulmagen Investigational Site
Ostrow Wilekopolski
Pulmagen Investigational Site
Poznan
Pulmagen Investigational Site
Proszowice
Pulmagen Investigational Site
Skierniewice
Pulmagen Investigational Site
Tarnów
Pulamgen Investigational Site
Warsaw
Pulmagen Investigational Site
Wilkowice-Bystra
Pulmagen Investigational Site
Wroclaw
Pulmagen Investigational Site
Zabrze
Pulmagen Investigational Site
Zgierz

Other trials in Poland

Germany14 sites

Pulmagen Investigational Site
Augsburg
Pulmagen Investigational Site
Bad Wörishofen
Pulmagen Investigational Site
Berlin
Pulmagen Investigational Site
Bonn
Pulmagen Investigational Site
Deggingen
Pulmagen Investigational Site
Dresden
Pulmagen Investigational Site
Geesthacht
Pulmagen Investigational Site
Hagen
Pulmagen Investigational Site
Hamburg
Pulmagen Investigational Site
Hanover
Pulmagen Investigational Site
Marburg
Pulmagen Investigational Site
Schwerin
Pulmagen Investigational Site
Teuchem
Pulmagen Investigational Site
Weyhe

Other trials in Germany

Czechia9 sites

Pulmagen Investigational Site
Beroun
Pulmagen Investigational Site
Brno
Pulmagen Investigational Site
Havlíčkův Brod
Pulmagen Investigational Site
Holešov
Pulmagen Investigational Site
Jaroměř
Pulmagen Investigational Site
Neratovice
Pulmagen Investigational Site
Svitavy
Pulmagen Investigational Site
Teplice
Pulmagen Investigational Site
Třemošná

Other trials in Czechia

Hungary7 sites

Pulmagen Investigational Site
Balassagyarmat
Pulmagen Investigational Site
Budapest
Pulmagen Investigational Site
Kaposvár
Pulmagen Investigational Site
Komló
Pulmagen Investigational Site
Pécs
Pulmagen Investigational Site
Százhalombatta
Pulmagen Investigational Site
Szombathely

Other trials in Hungary

Croatia4 sites

Pulmagen Investigational Site
Čakovec
Pulmagen Investigational Site
Sisak
Pulmagen Investigational Site
Varaždin
Pulmagen Investigational Site
Zagreb

Other trials in Croatia

About this study

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.

Read the 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.

Conditions: Asthma
Being tested: ADC3680, Placebo, montelukast
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADC3680Drug
ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
PlaceboDrug
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
montelukastDrug
montelukast for 12 weeks

Study groups in NCT01730027
Study group	Role	What they receive
ADC3680	Experimental	ADC3680 oral once daily Receives: Drug: ADC3680
Placebo	Placebo comparator	Placebo oral once daily Receives: Drug: Placebo
montelukast	Active comparator	montelukast oral once daily Receives: Drug: montelukast

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
Measured: 10 weeks
Adding montelukast to ADC3680 in improving lung function (FEV1)
Measured: 2 weeks

Secondary outcomes (16)

Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
Measured: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
Measured: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
Measured: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
Measured: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
Measured: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
Measured: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
Measured: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
Measured: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
Measured: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
Measured: 10 weeks
Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
Measured: 2 weeks
Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
Measured: 2 weeks
Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
Measured: 2 weeks
Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Dec 2014

First posted21 Nov 2012 (estimated)
Study startApr 2013
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01730027
Sponsor's protocol ID: ADC3680-07
Other IDs: 2012-003966-42
Status last verified: Oct 2017
First submitted: 9 Nov 2012
Last updated: 6 Oct 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01730027
Acronym / sponsor ID: ADC3680-07
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Pulmagen TherapeuticsIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
ADC3680	Experimental	Drug: ADC3680ADC3680 oral once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo oral once daily
montelukast	Active comparator	Drug: montelukastmontelukast oral once daily

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADC3680ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period	Drug	ADC3680
PlaceboPlacebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period	Drug	Placebo
montelukastmontelukast for 12 weeks	Drug	montelukast

Primary outcome

Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
Time frame: 10 weeks
Adding montelukast to ADC3680 in improving lung function (FEV1)
Time frame: 2 weeks

16 secondary outcomes

Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
Time frame: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
Time frame: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
Time frame: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
Time frame: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
Time frame: 10 weeks
Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
Time frame: 2 weeks
Safety of ADC3680 compared to placebo
Time frame: 10 weeks
Safety of a 2 week administration of ADC3680 in combination with montelukast
Time frame: 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.

Related trials for Asthma

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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

87 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADC3680 and montelukast in people with Asthma, run by Pulmagen Therapeutics at 87 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Poland, Germany, Czechia, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of ADC3680 compared with placebo in improving lung function (FEV1) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01730027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.