EUCTR2017-003980-36-GB进行中（未招募）1 期
A single-Centre, open-label, exploratory study of the effect of 20 mg ambroxol hydrochloride on cough reflex sensitivity in patients with acute cough. - A study of the effect of 20 mg ambroxol hydrochloride on cough refex
Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 14 人开始时间: 2017年11月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
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
- •1Be informed of the nature of the study and have provided written informed voluntary consent;
- •2Be able to speak, read, and understand English;
- •3Be males or females, of any race, between 18 and 80 years of age, inclusive;
- •4Subject has an acute cough and other symptoms consistent with a common cold /acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator or qualified designee based on findings from medical history review, full physical examination and vital signs;
- •5The onset of symptoms must be within 72 h of study enrolment;
- •6Have a Cough Severity VAS = 40 mm at Screening;
- •7Be in good general health (other than URTI) with no clinically relevant abnormalities based on the medical history, physical examination, and 12 lead electrocardiogram;
- •8Cough at least twice to all cough challenge Agents-citric acid, Capsaicin, ATP and distilled water cough challenges at baseline.
- •9If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use 2 forms of acceptable birth control from Screening through the Follow Up Visit; or if a male, they and/or their partner of child-bearing potential agree to use 1 form of acceptable birth control from Screening through the Follow Up Visit;
- •10Be able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •11History of asthma or other respiratory related disease
- •12Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (e.g., seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator
- •13Clinical features of a complication of the common cold during the physical examination at screening (e.g., otitis media, sinusitis, or pneumonia) with or without the need for systematic antibiotics
- •14Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain.
- •15Evidence of chest infection or pneumonia
- •16Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI
- •17Demonstrate more than two coughs to inhalation of the normal saline solution during baseline challenge
- •18Current smoker or individuals who have given up smoking within the past 6 months or those with >20 pack-year smoking history;
- •19Treatment with an ACE-inhibitor during the study or within 4 weeks prior to Screening
- •20History of opioid use within 1 week prior to baseline;
- •21Requiring concomitant therapy with prohibited medications (see Section 7.5)
- •22History of known or suspected allergy or hypersensitivity reactions to ambroxol (e.g., asthma, urticaria or allergic type any of the non-medicinal ingredients contained in study investigational products.
- •23Clinically significant abnormal electrocardiogram (ECG) at Screening;
- •24Personal or family history of congenital long QT syndrome or family history of sudden death;
- •25Pregnant or breastfeeding;
- •26Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion;
- •27Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial
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