Efficacy and safety of Prevenar 13 in people with asthma

Phase 1

Recruiting

• Conditions: Asthma; Respiratory - Asthma; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12614001003662
• Lead Sponsor: Hunter Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Symptomatic stable asthma [ACQ(6) > 0.75], confirmed variable airflow obstruction, maintenance therapy

Exclusion Criteria

Forced expiratory volume in 1 second (FEV1) < 40% predicted.. Received pneumococcal vaccination with Pneumovax in the past 12 months, or Prevenar ever. Current smoking (or having quit within 6 months of study entry). Cold or respiratory tract infection within 4 weeks of study entry. Pregnancy, breast feeding, possibility of becoming pregnant (unwilling to use contraception during the treatment phase). Inability to attend study visits. Participation in another investigative drug study within 4 weeks of study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induced sputum eosinophils- Sputum induction will be performed with selection and dispersion of muco-cellular clumps and performance of total and differential cell counts.[Assessed at screening visit, during two treatment visits, at the end of treatment visit, which is 4 weeks after treatment 2, and end of study visit which is 12 months after the first treatment.];Regulatory T cell numbers and functional responses-<br>Treg cell numbers and functional responses will be analysed in peripheral blood mononuclear cells through flow cytometry.[Assessed at the two treatment visits and at the end of treatment visit, which is 4 weeks after treatment 2.]

Secondary Outcome Measures

Name	Time	Method
Asthma symptoms- assessed using the Juniper Asthma Control Questionnaire (ACQ(6))[ACQ(6) will be assessed at screening visit, two treatment visits, end of treatment visit (4 weeks after treatment 2), and end of study visit (12 months after treatment 1)];Health status- assessed using the Juniper Asthma Quality of Life<br>Questionnaire (AQLQ).[AQLQ will be assessed at screening visit, two treatment visits, end of treatment visit (4 weeks after treatment 2), and end of study visit (12 months after treatment 1).]