Perform a Risk Assessment Based on the Content of the Protocol

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Table of Contents

Nature of the Study
Hazard Identification
Dose-Response Analysis
Exposure Quantification
Conclusion

Nature of the Study

This article documents the risk analysis carried out for a randomized, placebo-controlled study in acute severe asthma in children. The target population to be sampled in this research is identified as children aged between 2 years to 15 years who are brought to the hospital emergency departments and acute pediatric inpatient units suffering from severe acute asthma attacks. The study is to be conducted across 20-25 research sites throughout the United Kingdom. Overall investigation duration for each patient is decided to be 240 minutes along with a follow-up appraisal after one month of the treatment.

The research will be carefully phased. The patient or the subject will firstly be screened when brought to the research site. They will then be provided with information related to the trial treatment if they are found to meet the inclusion criteria and following that the treatment would be commenced as per the BTS guidelines. After twenty minutes of initial treatment as per standard practice, a trial screening evaluation will be carried out and an on paper informed approval will be acquired from the appropriate subjects. Trial assessments reveal the normal course of treatment conducted for this particular patient population and will be concluded at randomization, before conducting randomized therapy, and at 20, 40, 60, 120, 180, and 240 minutes after randomization. Follow-up feedback forms will be posted to the patients’ residences to be filled up and returned one-month post-treatment.

All cases enlisted into the research will be subject to customary treatment procedures according to standard guidelines, in addition to either asthmadrug1 or placebo. Children aged between 2 to 5 years will be slated to be dosed with 2.5 mg of nebulized salbutamol and 0.25 mg of ipratropium bromide combined with either asthmadrug1 or placebo at three instances with a twenty-minute interval between each dosage. Children above the age of 6 years will be slated to be dosed with 5 mg of nebulized salbutamol and 0.25 mg of ipratropium bromide combined with asthmadrug1 or placebo at three instances with a time interval of twenty minutes each.

The primary objective of this study is to find out the effect of asthmadrug1 when used as an add-on to nebulized salbutamol and ipratropium bromide for one hour in the children population suffering from acute severe asthma and whether its clinically beneficial as determined by the Asthma Severity Score (ASS) as evaluated against nebulized salbutamol, ipratropium bromide and placebo. In addition, the research also aims to find out whether asthmadrug1 employed as an appendage to nebulized salbutamol and ipratropium bromide for one hour in the children population suffering from acute severe asthma, as evaluated against nebulized salbutamol, ipratropium bromide mixed with placebo, influence the following issues:

Clinical consequences about added treatment/management when in the clinic/hospital and the duration of stay there;
Patient upshots relating to the quality of life, time away from educational facilities due to asthma attacks and healthcare resource ut,utilization throughout the subsequent month
Parent effects pertaining to time away from work over the next month
Overall expenditure to the NHS and society

Patients, particularly those belonging to the children population and suffering from acute severe asthma are usually admitted to hospitals for no less than 24 hours duration and thus have a substantial effect on healthcare resources in addition to resulting in time away from school and time away from work in case of the parents. This trial aims to inspect whether the stipulation of asthmadrug1 as an early intervention medication, in combination with normal courses of treatment, provides clinical progress as compared to standard therapy in isolation.

Hazard Identification

Acute asthma aggravation is one of the major reasons for patients coming to emergency departments of clinics and hospitals. Particularly with the mounting frequency of the children population who demonstrate symptoms of asthma and the comparatively high fraction of them being poorly monitored due to improper treatment facilities is a major issue or worry. Thus, this study looks at the perspective of using astmadrug1 as an adjunct to the normal course of treatment and its effectiveness as an asthma control drug. However, as with any other venture, there are issues, which are subject to risks and thus must be properly identified and tackled accordingly.

The first phase of the study involves screening and enrolment. In this case, it should be kept in mind that due to procedural constraints there may be some delay in providing treatment to the patient. However, this should not be the case, and considering the need for immediate attention, the patient should be instantaneously transferred to the medication unit where he/she can receive standard medications for the time being. In this scenario, the patient information and other approval forms must be provided to the accompanying parent or legally acceptable patient representative. After the screening phase in which depending upon the eligibility criteria and consent approval, the patient is enrolled or excluded from the study. The trial treatment for the participating patient starts immediately after the initial treatment as per existing standards and practices. In this case, there is a risk of delay in commencement of trial treatment, which might affect the patient’s health. This may be due to the unavailability of treatment kits and trial medications. Thus, clinicians should be responsible enough to ensure the ease of accessibility of treatment kits and trial medication at all times so that the patient does not suffer due to delay of commencement of treatment.

Dosage modifications, as per the guidelines provided by the study outline, are not permissible even if the condition of the patient deteriorates. This may jeopardize the wellbeing of the patient. However, adverse may set in and provisions should be kept for extreme cases. Thus, dosage may be altered or totally withdrawn in case the clinician authenticates cessation therapy or if the consent of the patient/patient representative is withdrawn during that phase.

Asthmadrug1 is an unlicensed medication product. Thus, its use is strictly restricted to the patients participating in this study. Hence, any further use of the issue is considered illegal and this may produce serious adverse effects. Thus monitoring the logistical operations involving the treatment kits is extremely important. Thus, conductors of the research must first estimate the requirements of each site of study to counter the risk of unavailability of su p,plies and site pharmacies should be provided with sufficient supplies accordingly. Site pharmacies must also authenticate the receipt of the supplies and all information must be recorded at the Data Coordination Center. If the supplies are preserved it should be done under proper temperature regulations as per site procedure. To prevent the further use of medication supplies the site trial manager must oversee that all unused treatment kits are returned to the pharmacy and are destroyed.

Confidentiality of the participant’s information is a major concern and the risk of leakage of information into the wrong hands should be prevented. It must be ensured that the information of the patient does not go into the hands of any third party. Howe that medical personnel new associated with the wellbeing of the patient should be provided with proper medical information and further, demographic information must be provided to the DCC, as they are responsible for sending and contacting the patient for post treatment follow-up.

The validity of the results may be affected if there is incomplete or insufficient data collection. Thus during screening, randomization treatment all relevant procedures must be recorded thoroughly on the CRF. As a ffollow-up up address, change cards must be provided if the family of the participant relocates within one month of the treatment. Further, in case the participant forgets to respond to the questionnaires all essential efforts must be made in order to remind a non-responding participant and the questionnaires must be resent if necessary.

Research inexperience of site medical teams may prove to be a significant hindrance in proper evaluations and assessment. Site trial managers and research coordination team must look into the issue properly and provide all necessary support to the site medical teams and all relevant parties to ensure that a proper assessment is carried out.

Dose-Response Analysis

Asthmadrug1 is an unlicensed medical product and is normally used to treat other symptoms. It is not a common practice to use it for providing medical attention to those suffering from acute severe asthma. When drawn on, it is usually injected intravenously, and it is advised that it should preferably not be used on children, as obtaining venous access is intricate and a horrible experience for children. In case of this trial, asthmadrug1 a milder dose is to be used than the dosage that is used when injected intravenously. This will be given by using a nebuliser for inhalation instead of injecting it. This will provide for canalizing the medication straight to the air-tracts and diminish any potential impacts of total administration. Data relating to the application of asthmadrug1 delivered through nebulisers is highly insubstantial. On the other hand, the adverse consequences outline when delivered intravenously is well substantiated. Documented unfavorable effects include increases in heart rate and dizziness. However, such effects are infrequent, mild, and patients recover quickly subsequent to termination of treatment. It is anticipated that patients treated with asthmadrug1 may undergo these low-level momentary experiences.

Exposure Quantification

Children aged between 2 to 5 years will be slated to be dosed with 2.5 mg of nebulised salbutamol and 0.25 mg of ipratropium bromide combined with either asthmadrug1 or placebo at three instances with a twenty minute interval between each dosage. Children above the age of 6 years will be slated to be dosed with 5 mg of nebulised salbutamol and 0.25 mg of ipratropium bromide combined with asthmadrug1 or placebo at three instances with a time interval of twenty minutes each.

To ensure the safety of the patient, his/her status should be medically observed for at least four hours. Oxygen saturation, respiratory rate and blood pressure should be documented after each 20-minute interval throughout the treatment duration. Follow up tests should be carried out at 2, 3 and 4 hours subsequent to the concluding study treatment. Other routine checks may also be carried out as a part of standard medical practices.

Conclusion

After identifying and evaluating the aforementioned risks involved and the procedures and practices, which can be, put in place to counter them, this trial can be deemed as a slightly moderate risk clinical trial with a risk assessment score of 37.0%.

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Perform a Risk Assessment Based on the Content of the Protocol

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