Phase IIa study to evaluate the effects of GPD-1116 on late phase asthmatic response to allergen challenge in asthmatic patients.

• Conditions: Asthma response to allergen challenge; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2008-005813-23-GB
• Lead Sponsor: ASKA Pharmaceutical.Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1.Adult males and females aged 18 to 50 years (inclusive).
2.Have a history of asthma as defined by the Global Initiative in Asthma definition or have been on treatment for asthma.
3.Subjects who if female, are post-menopausal/surgically sterile.
4.Subjects (male) who are using medically acceptable methods of contraception.
5.Subjects who have a pre-study medical history, physical examination and 12-lead ECG measurements acceptable to the Investigator.
6.Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator.
7.Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C virus and human immunodeficiency virus (HIV) I and II tests at screening.
8.Subjects who are negative for drugs of abuse and alcohol tests at screening and admission.
9.Regular or as the occasion arises (PRN) treatment of short acting ß agonists (SABA).
10.Positive response on screening of a skin prick test to house dust mite, cat hair or grass pollen. Subjects with documentation of a skin prick test in the last 12 months will not require this test.
11.Baseline (pre-bronchodilator) FEV1 =70% of predicted.
12.Baseline 20% fall in FEV1 (PC20) to methacholine of less than 8 mg/mL.
13.Subjects who have been non-smokers for at least 3 months prior to screening and have a <10 pack year smoking history.
14.The subject must demonstrate an EAR which must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen.
15.The subject must demonstrate a LAR which must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 h after the final concentration of allergen.
16.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 AEs. Subjects should continue their concomitant treatments without change during the study.
17.Subjects who are able and willing to give written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who do not conform to the above inclusion criteria.
2.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.
3.Subjects who have a clinically relevant surgical history which would preclude antigen challenge.
4.Subjects who have a clinically relevant family history which would preclude antigen challenge.
5.Subjects who have a history of relevant drug hypersensitivity.
6.Subjects who have a history of alcoholism.
7.Subjects who have a history of drug abuse.
8.Subjects who consume more than 21 units (male)/14 units (female) of alcohol a week. [unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer].
9.Subjects who have a significant infection or known inflammatory process on screening.
10.Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
11.Subjects who have an acute infection such as influenza at the time of screening or admission.
12.Subjects who have used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
13.Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zilueton, or anti cholinergic agents within 28 days prior to the screening visit.
14.Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
15.Subjects who have donated or received any blood or blood products within the previous 3 months prior to first dosing (to be reviewed on a case by case basis).
16.Subjects who cannot communicate reliably with the Investigator.
17.Subjects who are unlikely to co-operate with the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of repeated doses of GPD-1116 on the late phase asthmatic response to allergen challenge in mild to moderate asthmatic patients.;Secondary Objective: To examine the effects of GPD-1116 on the safety, tolerability, antigen induced airway hyperactivity, exhaled nitric oxide, sputum eosinophilia and early phase asthmatic response (EAR).;Primary end point(s): The primary endpoint will be a comparison of active vs. placebo on the late phase asthmatic response (LAR) to allergen challenge (LAR; 4 to 10 h after allergen challenge).