In Vivo Efficacy of Salbutamol (Sandoz) Versus Salbutamol Ventolin (GSK) in Children With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FEV1 (%) 100ug salbutamol
研究概览
简要总结
In this study, the investigators hypothesize that the reference product (SalbR/Ventolin) is more effective than SalbG (Salbutamol Sandoz) at improving the lung function in children with asthma, and that this difference increases alongside the severity of the airway resistance. (Null hypothesis: There is no difference).
This could be explained by different properties and deposition of the aerosol.
Purpose of this research:
Rejecting the null hypothesis. This is based on the answers to the questions below.
Research questions:
- Is there a difference between the increase in FEV1 (and FVC) after 100 μg SalbG versus FEV1 after 100 μg SalbR in children aged 4-14 years with insufficient asthma control? (primary question)
- Is there a difference in the subjective feeling of the children after inhalation with 100 μg SalbR and after 100 μg SalbG, measured with a VAS score?
- Is the increase in FEV1 (and FVC) in children with asthma between 4-14 years of age with insufficient asthma control after inhalation of 400 μg SalbR different than after inhalation of 400 μg SalbG?
- Is there a difference in the subjective feeling of the children after inhalation with 400 μg SalbR and after 400 μg SalbG, measured with a VAS score?
详细描述
Since 2016, pediatricians have regularly seen children with an asthma exacerbation, in which case salbutamol Sandoz was used as rescue medication in case of dyspnoea. The subjective impression is often that these children responded less well to this preparation in comparison to before or to the reference product, Ventolin.
After switching from the reference product (Ventolin, Salbutamol Reference, SalbR) to generic Salbutamol Sandoz (Salbutamol Generic, SalbG), parents also regularly spontaneously reported that they had the impression of reduced efficacy of SalbG.
Lareb received a striking number of reports in 2016 (63 of which 40 were reports concerning children) regarding an alleged reduced effect of SalbG compared to previous (reference) products containing salbutamol, such as Ventolin and Airomir. These reports mainly came after SalbG became the preferred drug of the Dutch health insurers.
In 2015, the concentration of SalbG in the aerosol dose doubled, whilst the release in micrograms would have remained the same, and oleic acid was added (as is also present in other dose aerosols).Reports received by Lareb came from both healthcare providers and (parents of) patients and did not clearly decrease in the course of 2016. An inventory via social media by the "LongFonds" clearly displayed the perception of lower efficacy amongst children as well as adults. This also led to a column in the broadcast of EenVandaag.
The CBG has studied and investigated the reports and signals, but has concluded that the quality control as carried out by the EMA was not a reason to remove Salbutamol Sandoz from the market. Various insurers have since accepted other generic products containing salbutamol in dose aerosol as an alternative instead of SalbG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent both parents in case of children aged < 12 years, informed consent both parents and patient of children aged 12-14 years
- •Patients classified as doctor's diagnosed asthma, preferably with confirmed bronchial hyperreactivity or reversibility (FEV1 > 9% predicted) in earlier lung function assessment and/or known efficacy of salbutamol as rescue medication (either subjective or clinically)
- •Indication for lung function assessment as part of regular medical care
- •A score of < 20 on the C-ACT (children astma control questionnaire, 4-11 years) or ACT (12-16 years) and/or FEV1 <10% when compared to personal's best and/or FEV1 < 80% predicted and/or actual subjective impression of dyspnea in such severity that patient or caretaker would normally have used their bronchusdilatator
排除标准
- •Status asthmaticus with a need for (continuous) nebulisation of salbutamol
- •Inability of performing a technically adequate and reliable lung function assessment
- •Inability of adequate instruction of patient and/or caretakers due to difficulty in communication and/or language barrier
- •Clinically relevant comorbidities with impact on the lung function assessment (eg (cardio)pulmonary disease, muscle disease etc)
研究组 & 干预措施
FEV1 >90%
Children with lung function FEV1 > 90%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 >90%
Children with lung function FEV1 > 90%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 >90%
Children with lung function FEV1 > 90%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 >90%
Children with lung function FEV1 > 90%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 80-90%
Children with lung function FEV1 80-90%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 80-90%
Children with lung function FEV1 80-90%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 80-90%
Children with lung function FEV1 80-90%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 80-90%
Children with lung function FEV1 80-90%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 70-80%
Children with lung function FEV1 70-80%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 70-80%
Children with lung function FEV1 70-80%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 70-80%
Children with lung function FEV1 70-80%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 70-80%
Children with lung function FEV1 70-80%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 60-70%
Children with lung function FEV1 60-70%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 60-70%
Children with lung function FEV1 60-70%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 60-70%
Children with lung function FEV1 60-70%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 60-70%
Children with lung function FEV1 60-70%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 < 60%
Children with lung function FEV1 < 60%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 < 60%
Children with lung function FEV1 < 60%
干预措施: "100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK" (Drug)
FEV1 < 60%
Children with lung function FEV1 < 60%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz" (Drug)
FEV1 < 60%
Children with lung function FEV1 < 60%
干预措施: "100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK" (Drug)
结局指标
主要结局
FEV1 (%) 100ug salbutamol
时间窗: baseline
FEV1 (%) after inhalation of 100 microgram salbutamol
次要结局
- FEV1 (%) 400ug salbutamol(baseline)
- VAS 400ug salbutamol(baseline)
- VAS 100ug salbutamol(baseline)
研究者
Ellen Croonen
dr. E Croonen, Principal Investigator
Canisius-Wilhelmina Hospital