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Allergic AsthmaPhase 2NCT00535431

Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics

A Phase 2 study testing AER 001 in people with Allergic Asthma, run by Aerovance, Inc. at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before and after treatment subjects will be experimentally challenged with inhaled allergen to induce decreases in lung function. 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
32 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2005to Oct 2006
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.
  • Adenosine monophosphate PC20 on screening of ≥ 0.04 mg/ml
  • Subjects, who on the Allergen challenge, have a PC20 on allergen and exhibit a late phase response following the allergen challenge.
  • Subjects who have a FEV1 > 70% of predicted.
  • Subjects who 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 (male)/ 21 units (female) of alcohol a week.
  • (unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer)
  • 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 respiratory 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.
  • Subjects who have previously taken AER 001

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Guy's Drug Research Unit, Quintiles, Ltd.

    London, SE1 1YR

Other trials in United Kingdom

About this study

Official title: A Study To Investigate The Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatic Subjects

This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before and after treatment subjects will be experimentally challenged with inhaled allergen to induce decreases in lung function. The primary outcome is late phase response to allergen as measured by the average percent change in FEV1 from 4-10 hours following allergen. Because AER 001 is a Th2 anti-inflammatory, it is hypothesized that AER 001 treatment will inhibit the late phase response to allergen challenge.

Read the detailed description

Objectives:

Primary Objective To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics

Secondary Objectives

  • To examine the effects of AER 001 on antigen induced airway hyperactivity to adenosine monophosphate and blood levels of circulating IgE.
  • To characterise the pharmacokinetics of nebulised AER 001.

Exploratory Objectives

  • To examine the effects of AER 001 on circulating sIL-13Rα2 and IFNgamma.
  • To examine the results of single nucleotide polymorphism (SNP) analysis of IL-4, IL-13, IL-4Rα and IL-13R α to determine if there is any correlation between AER 001 response and genotype
  • To examine levels of anti-AER 001 following administration of AER 001

Methodology:

  • Single centre, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects.
  • A sufficient number of subjects (at least 30 subjects) will be recruited to ensure that at least 26 completed sets of data will be obtained.
  • Subjects will be randomised to receive either AER 001 60 mg / matched volume Placebo in a ratio of 1 active : 1 placebo ( block size of 6).
  • Treatments will be administered by nebulization from a PARI LC Plus nebulizer
  • Subjects are to receive b.i.d. administration of AER 001 / placebo for 27 days. A morning dose will be given on Day 28, (24 hours after Day 27 am-dose).
Conditions
Allergic Asthma
Being tested
AER 001, placebo
Keywords
Asthma, allergy, interleukin-4, interleukin-13, IL-4, IL-13
Medical subject headings
Asthma, Hypersensitivity, Rhinitis, Allergic

What participants receive

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

  • AER 001Drug

    Also called AEROVANT

    60 mg (in nebuliser), twice daily for 28 days

  • placeboDrug

    Sterile saline nebulised, twice daily for 28 days

Study groups in NCT00535431
Study groupRoleWhat they receive
AExperimentalAER 001
Receives: Drug: AER 001
PPlacebo comparatorsterile saline
Receives: Drug: placebo

What is being measured

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

  1. To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics as measured by average percent fall in FEV1 from 4-10 hours post allergen challenge (i.e. the late phase response)after 28 days of treatment

    Measured: pre- vs. post 28 days of treatment

Secondary outcomes (1)

  1. Secondary Objectives • To examine the effects of AER 001 on antigen induced airway hyperactivity to adenosine monophosphate and blood levels of circulating IgE. • To characterise the pharmacokinetics of nebulised AER 001.

    Measured: pre- vs. post 28 days of treatment

Timeline

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

  1. First posted26 Sep 2007 (estimated)
  2. Study startDec 2005
  3. Study completionOct 2006

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00535431
Sponsor's protocol ID
QGUY/2005/AER 001/-03
Other IDs
EUDRACT 2005-004829-26
Status last verified
Sep 2007
First submitted
22 Sep 2007
Last updated
26 Sep 2007
Results posted
No
Data monitoring committee
No

Publications

  • Slager RE, Hawkins GA, Ampleford EJ, Bowden A, Stevens LE, Morton MT, Tomkinson A, Wenzel SE, Longphre M, Bleecker ER, Meyers DA. IL-4 receptor alpha polymorphisms are predictors of a pharmacogenetic response to a novel IL-4/IL-13 antagonist. J Allergy Clin Immunol. 2010 Oct;126(4):875-8. doi: 10.1016/j.jaci.2010.08.001. No abstract available.

    PubMed 20920778

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 18 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?

To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics as measured by average percent fall in FEV1 from 4-10 hours post allergen challenge (i.e. the late phase response)after 28 days of treatment (time frame: pre- vs. post 28 days of treatment). 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 NCT00535431, 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.

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