Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22,155
- 试验地点
- 3
- 主要终点
- Baseline frequency of patients with urinary retention
研究概览
简要总结
DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in Europe.
The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of use of new users of aclidinium bromide (monotherapy or in combination) and new users of other medications for chronic obstructive pulmonary disease (COPD); to evaluate the potential off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of patients for whom there is missing information in the risk management plan (RMP); and to establish a core cohort of new users of aclidinium bromide for the future evaluation of safety concerns described in the RMP.
The data source for these studies will be the CRPD in the UK, the GePaRD in Germany, and national health databases in Denmark.
详细描述
DUS1 will be conducted when the target number of new users of aclidinium monotherapy is reached, and DUS2 when the target number of new users of aclidinium fixed-dose combination with formoterol is reached.
As this was a descriptive study no primary or secondary endpoints were specified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases:
- •To have at least 1 year of enrolment in the database (DUS1 and DUS2).
- •To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1
- •To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2
- •The same inclusion criteria will be applied for each of the comparator drugs.
排除标准
- •No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.
研究组 & 干预措施
Aclidinium bromide monotherapy
In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included.
干预措施: Aclidinium bromide (Drug)
Aclidinium bromide and formoterol
In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included.
干预措施: Aclidinium bromide/formoterol (Drug)
New users of other COPD medication
New users of other COPD medications (tiotropium, other LAMAs, LABA, LABA/ICS, LAMA/LABA), prescribed as recorded in the database.
干预措施: Other COPD medication (Drug)
结局指标
主要结局
Baseline frequency of patients with urinary retention
时间窗: Baseline (date of first prescription)
Frequency of pregnancies during use of COPD medication
时间窗: From date of first prescription up to 1 year of follow-up
Baseline frequency of patients with narrow-angle glaucoma
时间窗: Baseline (date of first prescription)
Baseline age of new users
时间窗: Baseline (date of first prescription)
Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis
时间窗: Baseline (date of first prescription)
Baseline frequency of new users with severe COPD
时间窗: Baseline (date of first prescription)
COPD severity including recent exacerbations
Baseline frequency of new users with a history of cardiovascular disease
时间窗: Baseline (date of first prescription)
Baseline history of cardiovascular diseases and baseline cardiovascular risk profile, including diabetes, recent acute myocardial infarction (AMI), unstable angina, arrhythmias, or heart failure
Overall comorbidity index of new users
时间窗: From date of first prescription up to 1 year of follow-up
Frequency of respiratory medication use by new users
时间窗: From date of first prescription to 1 year of follow-up
Baseline gender of new users
时间窗: Baseline (date of first prescription)
Frequency of users of aclidinium bromide with comorbid asthma diagnoses or in the absence of other drugs or diagnoses suggestive of COPD
时间窗: From date of first prescription up to 1 year of follow-up
Frequency of use of aclidinium bromide in the pediatric population
时间窗: From date of first prescription up to 1 year of follow-up
Frequency of comorbid conditions in the paediatric population
时间窗: From date of first prescription up to 1 year of follow-up
Baseline frequency of patients with renal or hepatic impairment
时间窗: Baseline (date of first prescription)
Baseline frequency of patients who have experienced a recent exacerbation
时间窗: Baseline (date of first prescription
Baseline frequency of patients with thyrotoxicosis or pheochromocytoma
时间窗: Baseline (date of first prescription)
Frequency of previous smoking in new users
时间窗: From date of first prescription to 1 year of follow-up
Frequency of current smokers in new users
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI <18.50 kg/m2 (underweight)
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI ranging from 18.50 to 24.99 kg/m2 (normal weight)
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >25.0 kg/m2 (overweight)
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI ranging between 25.0 and 29.99 kg/m2 (pre-obese)
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >30 kg/m2 (obese)
时间窗: From date of first prescription to 1 year of follow-up
Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)
时间窗: From date of first prescription to 1 year of follow-up
Baseline frequency of patients with benign prostatic hyperplasia
时间窗: Baseline (date of first prescription)
Baseline frequency of patients with bladder neck obstruction
时间窗: Baseline (date of first prescription)
次要结局
- Duration of COPD medication use(From date of first prescription up to 1 year of follow-up)
- Average daily dose of COPD medication(From date of first prescription up to 1 year of follow-up)
- Adherence to COPD medication within 1 year(From date of first prescription up to 1 year of follow-up)
- Frequency of use of concomitant medications(From date of first prescription up to 1 year of follow-up)
- Frequency of switching between COPD medications(From date of first prescription up to 1 year of follow-up)
- Total number of prescriptions(From date of first prescription up to 1 year of follow-up)