EUCTR2013-004719-32-DK进行中（未招募）不适用
A single (assessor) - blind, randomised, three-period, cross-over study to compare the safety of flutiform® pMDI, fluticasone pMDI and beclometasone Autohaler® in paediatric subjects aged 5 to less than 12 years with mild persistent asthma by means of knemometry. - FLT2504
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •1.Male and Female subjects 5 to <12 years old. Female subjects must be pre-menarche to be eligible.
- •2.Subjects must be pre-adolescent without any signs of puberty (acc. to Tanner scale).
- •3.Subjects are in normal range for their age in height and weight. Weight and height measurements should fall within the percentile range 3-97-% of normal values for age according to Danish growth charts.
- •4.Known history of mild intermittent or persistent reversible asthma for = 3 months prior to the screening visit.
- •5.Require:
- •a.only inhaled SABA therapy (e.g. Bricanyl Turbuhaler) on an as required basis, and/or
- •b.Regular non-ICS controller medications for asthma (e.g., cromones or leukotriene receptor antagonists) at a stable dose for = 3 months prior to the screening visit.
- •6.No ICS for >2 weeks prior to the screening visit.
- •7.Demonstrates adequate spirometry technique and able to use a home PEFR meter.
- •8.Demonstrated FEV1 of = 80% predicted value at visit 1following appropriate withholding of asthma medications (if applicable) (no SABA use within 6 hours of the PFT).
- •9.Demonstrated satisfactory technique in the use of the pMDI plus spacer and Autohaler devices.
- •10.Must be continent of urine and willing to perform (with parental/guardian help) overnight urine collections.
- •11.Willing and able to complete morning and evening PEFR measures with the help of a parent or guardian, if necessary, and attend all study visits.
- •12.Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study with study medication.
- •13.Written informed consent obtained as per national laws.
- •Inclusion Criteria required following run-in:
- •14.FEV1 within =20% of the visit 1 value following appropriate withholding of rescue medication (no Airomir Autohaler use within 6 hours of the PFT).
- •15.Rescue medication use on =2 days during the last 7 days of the run in period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •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
排除标准
- •1.Require medications other than inhaled SABAs and/or regular non-ICS controller medications (e.g., cromones or leukotriene receptor antagonists) to maintain asthma control.
- •2.ICS use within = 2 weeks prior to the screening visit.
- •3.Any asthma exacerbation of any severity for at least 3 months prior to the screening visit.
- •4.Any fracture in the leg to be measured by knemometry =6 months prior to the screening visit.
- •5.Any metabolic disorders or other diseases that may impact on normal growth patterns.
- •6.Near fatal or life-threatening asthma within the past year.
- •7.Hospitalisation or an emergency visit for asthma within the past 6 months.
- •8.History of oral or injectable corticosteroid medication =3 months prior to the screening visit.
- •9.Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator’s opinion, preclude entry into the study. Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
- •10.No major surgery requiring general anesthesia for at least 3 months prior to the screening visit.
- •11.No febrile illnesses with temperature > 39°C within a week of the screening visit.
- •12.In the Investigator’s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit.
- •13.Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
- •14.Subjects who have taken ß- blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit.
- •15.Current use of medications, other than those allowed in the protocol.
- •16.Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components.
- •17.Receipt of an Investigational medicinal product within 30 days of the screening visit.
研究者
相似试验
招募中
2 期
A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 6 to <12 years) with moderate to-severe atopic dermatitis.Atopic dermatitisNL-OMON53683eo Pharma6
进行中（未招募）
1 期
Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis. TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1)Atopic dermatitisEUCTR2021-005573-12-NLEO Pharma A/S53
招募中
不适用
Clinical Trial to Investigate the Pain Reduce Effect of Kinesio Taping Therapy on Ankle SpraiDiseases of the musculo-skeletal system and connective tissueKCT0002257Dongshin University60
招募中
4 期
Study to check the efficacy and safety of topical Tofacitinib gel/ ointment with topical Tacrolimus gel/ ointment in facial vitiligo.CTRI/2024/02/062420Dr Imran Majid
招募中
不适用
A Clinical Study to Determine the Optimal Dose of Fat Reduction Injection (AYP-101) for the Reduction of Submental Fat in Chin AreaKCT0004034Amipharm140