EUCTR2012-004864-24-BE
Active, not recruiting
Phase 1
Randomized, placebo-controlled, double-blind, cross-over trial with Bronchipret and Sinupret to evaluate acceleration of mucociliary clearance (MCC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bionorica SE
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female volunteers 25 \- 40 years (females being non\-pregnant/non\-breast\-feeding and applying a safe method of contraception)
- •3\. Current smokers (5\-20 cigarettes per day since at least 5 years for a maximum of 20 years)
- •4\. Ability to taste sweetness of saccharin
- •5\. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve
- •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 56
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Ciliary dyskinesia
- •2\. Cystic fibrosis
- •3\. COPD/emphysema
- •5\. Chronic rhinosinusitis
- •6\. Acute respiratory tract infection within the last 6 weeks prior to enrolment
- •7\. Septal or sinus surgery
- •8\. Symptomatic allergic rhinitis
- •9\. Known allergic rhinitis
- •10\. Treatment with not\-permitted previous or concomitant therapy
- •11\. History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month
Outcomes
Primary Outcomes
Not specified
Similar Trials
Suspended
Phase 2
Efficacy and safety of a Chinese herbal medicine to reduce hot flushes/night sweats in women treated for breast cancerACTRN12617001247369Western Sydney University84
Active, not recruiting
Not Applicable
Clinical study with randomly into groups divided patients (investigational or ineffective control medication), where neither the doctor nor the patient's know the assignment, to determine the effect of the investigational product (Empagliflozin) on the circulation in the smallest vessels of the body.Type 2 diabetes mellitusMedDRA version: 17.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2014-003053-34-DEIPPMed – Institut für Pharmakologie und Präventive Medizin GmbH
Completed
Not Applicable
Influence of Silexan on pharmacokinetics and hormonal activity in females taking oral contraceptivesPharmacokinetics of ethinyl estradiol and levonorgestrelNot ApplicableISRCTN52706881Dr. Willmar Schwabe GmbH & Co. KG (Germany)24
Active, not recruiting
Phase 1
A controlled study in patients with Indolent Systemic Mastocytosis to determine the safety and efficacy of PA101 when compared with an existing drug and a placeboIndolent Systemic MastocytosisMedDRA version: 18.1Level: PTClassification code 10042949Term: Systemic mastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2014-004113-85-DEPatara Pharma, LLC36
Active, not recruiting
Phase 1
A controlled study in patients with Indolent Systemic Mastocytosis to determine the safety and efficacy of PA101 when compared with an existing drug and a placeboIndolent Systemic MastocytosisMedDRA version: 17.1Level: PTClassification code 10042949Term: Systemic mastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2014-004113-85-ESPatara Pharma, LLC36