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

NCT00535431 | Completed Phase 2

• 2 other identifiers: QGUY/2005/AER 001/-03EUDRACT 2005-004829-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Asthma

Keywords

Asthma; allergy; interleukin-4; interleukin-13; IL-4; IL-13

Outcome Measures

Primary Outcomes (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

  pre- vs. post 28 days of treatment

Secondary Outcomes (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.

  pre- vs. post 28 days of treatment

Study Arms (2)

A

EXPERIMENTAL

AER 001

Drug: AER 001

P

PLACEBO COMPARATOR

sterile saline

Drug: placebo

Interventions

AER 001 DRUG

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

Also known as: AEROVANT

A

placebo DRUG

Sterile saline nebulised, twice daily for 28 days

P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aerovance, Inc.: lead

Study Sites (1)

Guy's Drug Research Unit, Quintiles, Ltd.

London, SE1 1YR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20920778 DERIVED

MeSH Terms

Conditions

Asthma; Hypersensitivity; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Darren Wilbraham, MD

  Guy's Drug Research Unit, Quintiles Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2007
• First Posted: September 26, 2007
• Study Start: December 1, 2005
• Study Completion: October 1, 2006
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

GB (1)