Allergic AsthmaPhase 2NCT00535028
A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)
A Phase 2 study testing AER 001 in people with Allergic Asthma, run by Aerovance, Inc. at 1 site in United Kingdom.
Trial summary
This is a single center, double-blind, randomised parallel group design study to investigate the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is to be administered subcutaneously (25 mg, once daily) for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- AER 001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to May 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adult males and females > 18 years.
- Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
- Subjects who have a pre study medical history, physical examination, 12 Lead ECG acceptable to the investigator.
- Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
- Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
- Subjects who are negative for drugs of abuse and alcohol tests at screening and admission.
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- Positive response on screening to a skin prick test.
- Subjects who respond < 8 mg / mL on the methacholine challenge.
- Subjects, who on the Allergen challenge, have a PC20 on allergen and exhibit a late phase response (>or = 15% between 4-10h) following the allergen challenge.
- Subjects who have a FEV1 >70% of predicted.
- Have not received steroid treatment in the prior month.
- Subjects who are non-smokers for at least 3 months prior to screening.
- Have a < 10 pack year history.
- Satisfies the Global Initiative in Asthma (GINA, 2002) definition of asthma or have been on treatment for asthma.
- Subjects with stable, adequately treated medical conditions may be enrolled provided the Principal Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments without change during the study.
- Subjects who are able and willing to give written informed consent.
Who cannot join
- • Subjects who do not conform to the above inclusion criteria.
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. Which would preclude antigen challenge
- Subjects who have a clinically relevant surgical history. Which would preclude antigen challenge
- Subjects who have a clinically relevant family history. Which would preclude antigen challenge
- Subjects who have a history of relevant drug hypersensitivity.
- Subjects who have a history of alcoholism.
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- Subjects who have a history of drug abuse.
- Subjects who consume more than 28 units of alcohol a week. (unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer)
- Subjects who have a significant infection or known inflammatory process on screening.
- Subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
- Subjects who have an acute infection such as influenza at the time of screening and/or admission.
- Female subjects who are not using an acceptable method of contraception.
- Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
- Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
- Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
- Subjects who cannot communicate reliably with the investigator.
- Subjects who are unlikely to co-operate with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's Drug Research Unit, Quintiles, Ltd.
6 Newcomen Street London, London, SE1 1YR
About this study
Official title: A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.
This is a single center, double-blind, randomised parallel group design study to investigate the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects will be challenged with allergen both before and after AER 001 treatment (at screen and at Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from 4-10 hours after an allergen challenge).
Read the detailed description
Objectives:
Primary Objective
- To investigate the late asthmatic response in mild to moderate asthmatics.. Secondary Objectives
- To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.
Methodology: Study Design:
- Single centre, phase IIa, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects.
- A sufficient number of subjects (at least 24 subjects) will be recruited to ensure that at least 20 completed sets of data will be obtained.
- Subjects will be randomised to receive either AER 001 25 mg / Placebo in a ratio of 1 active : 1 placebo.
- Treatments will be administered as a sub-cutaneous injection.
- Subjects are to receive a daily administration of AER 001 / placebo over a 4 week period.
- Subjects will be admitted to the unit at least 2 hours prior to the first dose administration. On the first dosing occasion the subjects will remain in the unit under clinical supervision for at least 30 minutes post dose or until the Investigator is satisfied for them to be discharged. On subsequent dosing days the subjects will be admitted to the unit at least 45 minutes prior to dosing and remain in the unit for at least 15 minutes post dose or until the Investigator is satisfied for them to be discharged.
- Conditions
- Allergic Asthma
- Being tested
- AER 001, placebo
- Keywords
- asthma, allergy, interleukin-4, interleukin-13, IL-4, IL-13, atopic, late asthmatic response, inflammation
- Medical subject headings
- Asthma, Hypersensitivity, Rhinitis, Allergic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER 001Drug
AER 001 25 mgs s.c. once daily for 28 days
placeboDrug
sterile saline
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AER 001 s.c. once daily for 28 days Receives: Drug: AER 001 |
| P | Placebo comparator | placebo s.c. once daily for 28 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max %fall in FEV1 during the late phase asthmatic response (4-10 hours after allergen challenge)
Measured: After 28 days of treatment with study medication
Secondary outcomes (1)
To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.
Measured: After 28 days of treatment with study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerovance, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Darren Wilbraham, M.D., Principal investigator, Guy's Drug Research Unit, Quintiles, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535028
- Sponsor's protocol ID
- QGUY/2004/IL4-13/-01
- Other IDs
- EUDRACT 2004-002836-25
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wenzel S, Wilbraham D, Fuller R, Getz EB, Longphre M. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet. 2007 Oct 20;370(9596):1422-31. doi: 10.1016/S0140-6736(07)61600-6.
PubMed 17950857
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.
- ClinicalTrials.gov ID
- NCT00535028
- Acronym / sponsor ID
- QGUY/2004/IL4-13/-01
- Conditions
- Allergic Asthma
- Keywords
- asthma, allergy, interleukin-4, interleukin-13, IL-4, IL-13, atopic, late asthmatic response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aerovance, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jan 2005
- Study completion
- May 2005 (actual)
- First posted
- 26 Sep 2007 (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 is a single center, double-blind, randomised parallel group design study to investigate the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects will be challenged with allergen both before and after AER 001 treatment (at screen and at Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from 4-10 hours after an allergen challenge).
Detailed description
Objectives:
Primary Objective
- To investigate the late asthmatic response in mild to moderate asthmatics.. Secondary Objectives
- To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.
Methodology: Study Design:
- Single centre, phase IIa, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects.
- A sufficient number of subjects (at least 24 subjects) will be recruited to ensure that at least 20 completed sets of data will be obtained.
- Subjects will be randomised to receive either AER 001 25 mg / Placebo in a ratio of 1 active : 1 placebo.
- Treatments will be administered as a sub-cutaneous injection.
- Subjects are to receive a daily administration of AER 001 / placebo over a 4 week period.
- Subjects will be admitted to the unit at least 2 hours prior to the first dose administration. On the first dosing occasion the subjects will remain in the unit under clinical supervision for at least 30 minutes post dose or until the Investigator is satisfied for them to be discharged. On subsequent dosing days the subjects will be admitted to the unit at least 45 minutes prior to dosing and remain in the unit for at least 15 minutes post dose or until the Investigator is satisfied for them to be discharged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AER 001AER 001 s.c. once daily for 28 days |
| P | Placebo comparator | Drug: placeboplacebo s.c. once daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- • Adult males and females > 18 years.
Key exclusion criteria (17 listed)
- • Subjects who do not conform to the above inclusion criteria.
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 |
|---|---|---|
| AER 001AER 001 25 mgs s.c. once daily for 28 days | Drug | A |
| placebosterile saline | Drug | P |
Primary outcome
Max %fall in FEV1 during the late phase asthmatic response (4-10 hours after allergen challenge)
Time frame: After 28 days of treatment with study medication
1 secondary outcome
To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.
Time frame: After 28 days of treatment with study medication
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 26 Sep 2007.
- Derived from this study: PubMed 17950857Wenzel S, Wilbraham D, Fuller R, Getz EB, Longphre M. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet. 2007 Oct 20;370(9596):1422-31. doi: 10.1016/S0140-6736(07)61600-6.
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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.
Darren Wilbraham, M.D. principal investigator
Guy's Drug Research Unit, Quintiles, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AER 001 in people with Allergic Asthma, run by Aerovance, Inc. at 1 site 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 16 inclusion and 17 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 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Max %fall in FEV1 during the late phase asthmatic response (4-10 hours after allergen challenge) (time frame: After 28 days of treatment with study medication). 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 NCT00535028, which also lists 1 linked publication.
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 26 Sep 2007.