Tolerability of ALK Tree Tablet

This study has been completed.

Sponsor:

Information provided by:

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT00535639

First received: September 25, 2007

Last updated: February 28, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 25, 2007

Last Updated Date

February 28, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00535639 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tolerability of ALK Tree Tablet

Official Title ^ICMJE

A Randomised, Multiple Dose, Dose Escalation, Double-Blind, Placebo-Controlled Phase I Study Investigating the Safety of ALK Tree Tablet in Adult Subjects With Birch Pollen Induced Rhinoconjunctivitis (With/Without Asthma).

Brief Summary

This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Condition ^ICMJE

Allergy

Intervention ^ICMJE

Drug: Betula Verrucosa allergen extract

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season.
Positive Skin Prick Test response to Betula verrucosa
Positive specific IgE against Bet v1
FEV1 ≥ 70% of predicted value

Exclusion Criteria:

No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised
No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
No conjunctivitis, rhinitis or asthma at the screening or randomisation visit
No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
No history of angioedema

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00535639

Other Study ID Numbers ^ICMJE

TT-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

ALK-Abelló A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kim Krogsgaard, MD

PhaseOne Trials

Information Provided By

ALK-Abelló A/S

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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