Atopic AsthmaPhase 2NCT01448954
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
A Phase 2 study testing ADC3680B oral in people with Atopic Asthma, run by Pulmagen Therapeutics at 2 sites in United Kingdom.
Trial summary
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- ADC3680B oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2011to Feb 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Partially controlled mild-moderate atopic asthma
- Receiving inhaled corticosteroids
- Non-smoker or former smoker
- Males and females aged 18 to 55 years inclusive
- If female, must be of non-childbearing potential
Who cannot join
- History of acute severe asthma attacks
- History of COPD
- Other serious respiratory or other medical condition which may interfere with the outcome of the study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
Belfast, BT9 6AD
Study site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.
- Conditions
- Atopic Asthma
- Being tested
- ADC3680B oral, Placebo oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC3680B oralDrug
Once daily for 28 days
Placebo oralDrug
Once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ADC3680B oral | Experimental | Not described Receives: Drug: ADC3680B oral |
| Placebo oral | Placebo comparator | Not described Receives: Drug: Placebo oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
Measured: Baseline to Day 35
Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety
Measured: Baseline to Day 35
Evaluation of the change in vital signs as a measure of safety
Measured: Baseline to Day 35
Evaluation of the change in Pulmonary function as a measure of safety and tolerability
Measured: Baseline to Day 35
Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability
Measured: Baseline to Day 28
Secondary outcomes (2)
Determination of concentrations of ADC3680B in plasma
Measured: Days 1-2 and Days 28-30
Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood
Measured: Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmagen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448954
- Sponsor's protocol ID
- ADC3680-04
- Status last verified
- Feb 2012
- First submitted
- 26 Sep 2011
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
- ClinicalTrials.gov ID
- NCT01448954
- Acronym / sponsor ID
- ADC3680-04
- Conditions
- Atopic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pulmagen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Oct 2011 (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.
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADC3680B oral | Experimental | Drug: ADC3680B oral |
| Placebo oral | Placebo comparator | Drug: Placebo oral |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Partially controlled mild-moderate atopic asthma
- Receiving inhaled corticosteroids
- Non-smoker or former smoker
- Males and females aged 18 to 55 years inclusive
- If female, must be of non-childbearing potential
Key exclusion criteria (3 listed)
- History of acute severe asthma attacks
- History of COPD
- Other serious respiratory or other medical condition which may interfere with the outcome of the study
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 |
|---|---|---|
| ADC3680B oralOnce daily for 28 days | Drug | ADC3680B oral |
| Placebo oralOnce daily for 28 days | Drug | Placebo oral |
Primary outcome
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
Time frame: Baseline to Day 35
Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety
Time frame: Baseline to Day 35
Evaluation of the change in vital signs as a measure of safety
Time frame: Baseline to Day 35
Evaluation of the change in Pulmonary function as a measure of safety and tolerability
Time frame: Baseline to Day 35
Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability
Time frame: Baseline to Day 28
2 secondary outcomes
Determination of concentrations of ADC3680B in plasma
Time frame: Days 1-2 and Days 28-30
Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood
Time frame: Day 1 and Day 28
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 20 Feb 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADC3680B oral in people with Atopic Asthma, run by Pulmagen Therapeutics at 2 sites in United Kingdom.
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 5 inclusion and 3 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 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability (time frame: Baseline to Day 35). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2012.