To Evaluate Adenosine Monophosphate and Allergen Challeng... | NCT00679250

Studies
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

NCT00679250

Sponsor

Brian J Lipworth

Status

Completed

Last Update Posted

Apr 12, 2019Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

Allergic Rhinitis

Interventions

levocetirizine
placebo to levocetirizine

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-000683-27

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

May 14, 2008

First Submission Date that Met QC Criteria

May 15, 2008

First Posted Date

May 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2019

Last Update Posted Date

Apr 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levocetirizine	Experimental	Active drug	Drug: levocetirizine
placebo	Placebo Comparator	placebo to levocetirizine	Drug: placebo to levocetirizine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levocetirizine	Drug	5 mg once nightly before visit	Levocetirizine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Recovery Time Profile after nasal AMP and Allergen challenge		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 16-75
Patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms
Patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms
Concomitant asthma is permitted in those with rhinitis if FEV1 >60%
No recent exacerbations of asthma or chest infections if asthmatic
Able to perform all of the techniques necessary to carry out challenge testing
Must be compliant to study medication
Must give informed consent

Exclusion Criteria:

Male or female outwith the above age range
Negative skin prick testing
Patients with concomitant asthma with FEV1 less than 60% predicted
Patients with asthma with recent chest infection or exacerbation
Pregnant females, those at risk of becoming pregnant or breast feeding. Females must be on adequate contraception for the whole study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arun Nair, MRCP	University of Dundee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)		Dundee	Angus	DD1 9SY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12789212	Background	Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. doi: 10.1067/mai.2003.1592.
11707753	Background	Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity