7 Project Plan for Phase 3 Asthma Study Student’s Name Institutional Affiliation

7

Project Plan for Phase 3 Asthma Study

Student’s Name

Institutional Affiliation

Course Code and Name

Professor’s Name

Date

Project Plan for Phase 3 Asthma Study

Specific Aims

Phase 3 asthma study aims to appraise the safety and efficacy of Pfizer’s, a drug under investigation, in the reduction of exacerbations of asthma in patients in Canada compared to the asthma standard therapy. This project’s goal is to demonstrate that the investigational drug Pfizer has better asthma control and reduces asthma exacerbations compared to the current asthma therapy in the country.

Background

Asthma is a chronic disease of the lung that is characterized by swelling and narrowing of airways, which get blocked by excess mucus(Hashmi et al., 2024). This disease affects several individuals and populations, impairing the country socioeconomically and reducing the quality of life for individuals. The effects of asthma are severe, sometimes requiring frequent visits to the hospitals as well as sometimes calls for school and work absenteeism, reducing productivity. The treatment plan for asthma is expensive, including medication, hospital bills, and even home management, which often causes financial constraints for the sick individual and family(Nunes et al., 2019). Due to these impacts, it is necessary to develop and implement other innovative treatment therapies that aim to improve the outcomes of patients and minimize asthma treatment expenditure.

Significance of the study

This study is significant since it aims to analyze a new asthma therapy that will improve the outcomes of treatment and improve asthma care by reducing asthma exacerbations in patients. The success of this study will shed light on asthma management strategies that aim to reduce the asthma burden among the population. This will provide credible evidence to guide Canadian healthcare professionals in making choices in asthma treatment drug choices.

Study Design

A randomized controlled trial (RCT) design will be used for this study(Zabor et al., 2020). The variables for this study are rates of exacerbation and control measures. The relationship between these two variables will be measured to determine the ability of the investigational drug to improve patient outcomes. The study’s comparators will be the current standard therapies for asthma management. The study’s conceptual framework will evaluate the impact of the drug under investigation on the reduction of asthma exacerbations compared to the known asthma therapy. The patients in the study will provide a report on the outcomes following the use of the drug under investigation, and those reports will be used to determine the safety and efficacy of the drug. Methods of analyzing data will be aligned to the aim of the study, where analysis of subgroups will be done to evaluate the impacts of treatment.

Investigator was selected for the study.

The selection of the most appropriate investigator will be based on their location, their recruitment potential, and their feasibility. Based on these criteria, this study’s potential investigator is Dr. Garcia, located in Downtown Vancouver; Dr. Garcia demonstrates feasibility with a recruitment potential of 3-5 participants per month and may understand the study population better. Dr. Hassan, located in Halifax, NS, Central, shows feasibility with a 2-3 participants recruitment rate per month. Lastly, Dr. Auger, located in New Market, ON, shows feasibility with a 3-5 participants recruitment rate per month with networking capabilities with local hospitals. His network with local hospitals increases the chances of patient recruitment. All these three investigators will be considered for site selection in this study.

Participant selection

The study will recruit asthma patients ages 18 and 65 from all 15 different sites in Canada to ensure diverse patient demographics. Participants will be recruited through referrals by physicians and community outreach programs. Primarily, the participants will recruited from the 15 selected sites, with a total number of 600 study participants selected to be screened.

The study timeline

Activity

Date

Final protocol

30 January

final draft ICF

30 January

Feasibility and site selection

Start 16th JAN-5th MARCH

Submission to regulatory

13 February – 13 April

Submission to ethics and approval

13 February

Approval of first to the last centres

19th March-9th July

Shipment of drugs and laboratory kits to the first site

24-26th March

The first centre initiated, and the last centre initiated

26 March

First participant’s visit

2 April

The last participant’s first visit

30 July

Last participant’s visit

30 November

Database cleaned and locked

21 December

Data released

28 December

Completion of statistical analysis

4 December

Complete Clinical study report

11 December

Study Resources

The study comprises capable and experienced researchers, and the environment is conducive and well-equipped.

Dissemination and Implementation

The results of this study will be publicized through publications and scientific journals. During patient follow-up clinics, the patients will be educated on the findings. Dissemination of the study findings may be bared by resistance to change in healthcare clinical practice.

Protection of Human Subjects

Ethical guidelines on human subjects will guide the study by ensuring consent is obtained from all study participants before being included in the study. Approval to conduct the study will be obtained from the Institutional Review Board (Lapid et al., 2019).

Subcontracted organizations impacts

The management of data and statistical analysis will require assistance from subcontracted organizations, as well as the writing of reports. These organizations will ensure accurate and timely project completion.

References

Hashmi, M. F., Tariq, M., & Cataletto, M. E. (2024). Asthma. In StatPearls. StatPearls Publishing. http://www.ncbi.nlm.nih.gov/books/NBK430901/

Lapid, M. I., Clarke, B. L., & Wright, R. S. (2019). Institutional Review Boards: What Clinician Researchers Need to Know. Mayo Clinic Proceedings, 94(3), 515–525. https://doi.org/10.1016/j.mayocp.2019.01.020

Nunes, C., Pereira, A. M., & Morais-Almeida, M. (2017). Asthma costs and social impact. Asthma Research and Practice, 3, 1. https://doi.org/10.1186/s40733-016-0029-3

Zabor, E. C., Kaizer, A. M., & Hobbs, B. P. (2020). Randomized Controlled Trials. Chest, 158(1S), S79–S87. https://doi.org/10.1016/j.chest.2020.03.013