EUCTR2014-003846-29-GB进行中（未招募）1 期
A Phase IIA randomized, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled RNS60 and Budesonide on the late phase asthmatic response to allergen challenge in patients with mild asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male and female subjects aged 18 to 65 years inclusive;
- •Subjects with a body weight =50 kg and a body mass index (BMI) between 18.0 - 32.0
- •Subjects should be steroid-naïve (within 3 months of screening for oral corticosteroids and within 28 days of screening for inhaled corticosteroids), with mild asthma, but be otherwise healthy;
- •Male subjects should agree to not donate sperm from first dose until 3 months post-last dose;
- •Male subjects (with female partners of child bearing potential) and female subjects of child bearing potential should use two methods of highly effective contraception;
- •Subjects should be non-smokers; ex-smokers must not have smoked for at least 12 months, and have smoked less than a packet of cigarettes a day for 10 years, or equivalent;
- •Subjects should be taking only reliever medication for their asthma Antihistamines will be permitted up to 7 days prior to the first screening visit;
- •Lung function (blowing tests) must be 70% of the predicted normal value for age, height and sex at screening and prior to first dose administration;
- •Must show significant irritability of the airways when inhaling a mist of methacholine
- •Documented allergy to at least one common allergen (house dust mite, grass pollen allergens or cat dander) as confirmed by a skin prick test. Historical data (up to 1 year) may be used;
- •Must show significant irritability of the airways when inhaling a mist of an allergen they’re allergic to on skin prick testing.
- •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 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with evidence or history of clinically significant illness (excluding mild asthma);
- •Significant worsening of asthma in the 4 weeks preceding the screening visit requiring treatment above and beyond the usual preventer;
- •A respiratory infection in the 4 weeks preceding the first screening visit or prior to Day 1, Period 1;
- •Use of any immunotherapy within 3 months prior to first screening;
- •Regular use of medications;
- •Use of preventer medication for the treatment of asthma in the 4 weeks before screening is not allowed, and throughout participation in the study;
- •Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
- •History of life-threatening asthma;
- •Nasal Symptoms of allergy requiring treatment, at screening or predicted to require treatment during the study;
- •History of severe allergy;
- •Clinically significant abnormalities found on physical examination or in laboratory test results;
- •Subjects who have received any investigational drug in any clinical trial within 3 months, or who are on extended follow-up;
- •Subjects who are vegans or have medical dietary restrictions;
- •Patients who take concomitant treatment with herbal medication/supplements or St John’s Wort;
- •Subjects with a supine systolic blood pressure (SBP) =160 mmHg or a supine diastolic blood pressure (DBP) =100 mmHg at screening or prior to Day 1 Period 1;
- •History of alcohol abuse or drug addiction or positive alcohol test;
- •Positive screen on hepatitis B, hepatitis C, or antibodies to the human immunodeficiency virus (HIV);
- •Clinically significant abnormal 12-lead ECG or one demonstrating QTcF >450 ms at screening;
- •Significantly abnormal liver enzymes (alanine aminotransferase [ALT] >1.5 x upper limit of normal [ULN] or total bilirubin >1.5x ULN);
- •Subjects who cannot communicate reliably with the Investigator; and
- •Subjects who are unlikely to co-operate with the requirements of the study.
研究者
相似试验
进行中（未招募）
不适用
A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Intended Indication is Neuropathic PainMedDRA version: 9.1Level: LLTClassification code 10029223Term: NeuralgiaEUCTR2009-012094-35-DKAstraZeneca AB90
进行中（未招募）
1 期
A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Intended Indication is Neuropathic PainMedDRA version: 9.1Level: LLTClassification code 10029223Term: NeuralgiaEUCTR2009-012094-35-FRAstraZeneca AB90
进行中（未招募）
不适用
A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)Intended Indication is Neuropathic PainMedDRA version: 9.1Level: LLTClassification code 10029223Term: NeuralgiaEUCTR2009-012094-35-GBAstraZeneca AB90
进行中（未招募）
1 期
Abituzumab in SSc-ILDEUCTR2015-005023-11-ESMerck KGaA175
进行中（未招募）
1 期
Abituzumab in SSc-ILDSystemic sclerosis-associated interstitial lung disease (SSc-ILD)MedDRA version: 20.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 100000004855EUCTR2015-005023-11-GBMerck KGaA24