Trial Outcomes & Findings for Safety of Nasal Influenza Immunisation in Children With Asthma (NCT NCT02866942)

Results Overview

The validated questionnaire to be used will depend on the age of the enrolled child: * Age 2-4 years: TRACK questionnaire * Age 5-11 years: Children's Asthma Control Test (C-ACT) score * Age 12+ years: Asthma Control Test (ACT) score The change in score (using the appropriate questionnaire for age) between pre- and 4 weeks post LAIV will be used to assess the primary outcome across all participants. a change in (c-)ACT of at least 3 points, or 10 points for TRACK will be determined a significant change. For TRACK, the minimum and maximum score possible is 0 and 100 respectively, the higher the score, the better is symptom control. For c-ACT, the minimum and maximum score possible is 0 and 27 respectively, the higher the score, the better controlled are asthma symptoms. For ACT, the minimum and maximum score possible is 5 and 25 respectively, the higher the score, the better controlled are asthma symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

479 participants

Primary outcome timeframe

4 weeks post LAIV

Results posted on

2019-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Asthma LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Overall Study STARTED	479
Overall Study COMPLETED	478
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Asthma LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Overall Study Invalid consent	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthma n=478 Participants LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Age, Categorical <=18 years	476 Participants n=478 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=478 Participants
Age, Categorical >=65 years	0 Participants n=478 Participants
Age, Continuous	9.3 years n=478 Participants
Sex: Female, Male Female	190 Participants n=478 Participants
Sex: Female, Male Male	288 Participants n=478 Participants
Region of Enrollment United Kingdom	478 participants n=478 Participants
British Thoracic Society (BTS) Treatment Step 4+	229 Participants n=478 Participants

PRIMARY outcome

Timeframe: 4 weeks post LAIV

Population: 4 week follow-up data available in 319/478 participants

The validated questionnaire to be used will depend on the age of the enrolled child: * Age 2-4 years: TRACK questionnaire * Age 5-11 years: Children's Asthma Control Test (C-ACT) score * Age 12+ years: Asthma Control Test (ACT) score The change in score (using the appropriate questionnaire for age) between pre- and 4 weeks post LAIV will be used to assess the primary outcome across all participants. a change in (c-)ACT of at least 3 points, or 10 points for TRACK will be determined a significant change. For TRACK, the minimum and maximum score possible is 0 and 100 respectively, the higher the score, the better is symptom control. For c-ACT, the minimum and maximum score possible is 0 and 27 respectively, the higher the score, the better controlled are asthma symptoms. For ACT, the minimum and maximum score possible is 5 and 25 respectively, the higher the score, the better controlled are asthma symptoms.

Outcome measures

Outcome measures
Measure	Asthma n=319 Participants LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire Improvement >= MID	28 Participants
Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire No change	254 Participants
Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire Deterioration >= MID	37 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks post LAIV administration

Incidence of a 'significant exacerbation' in asthma, defined as: i. At least 3 day course of oral steroids following an unscheduled contact with a healthcare professional; OR ii. Unscheduled visit to an Emergency department or admission to hospital for treatment of asthma symptoms, requiring systemic corticosteroids

Outcome measures

Outcome measures
Measure	Asthma n=319 Participants LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV	47 Participants

Adverse Events

Asthma

Serious events: 4 serious events

Other events: 150 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Asthma n=478 participants at risk LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
Respiratory, thoracic and mediastinal disorders Wheezing	0.84% 4/478 • Number of events 4 • 72 hours post LAIV administration

Other adverse events

Other adverse events
Measure	Asthma n=478 participants at risk LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+ Administration of Live attenuated influenza vaccine (LAIV)
General disorders Malaise	8.8% 42/478 • Number of events 42 • 72 hours post LAIV administration
Respiratory, thoracic and mediastinal disorders Rhinitis	11.3% 54/478 • Number of events 54 • 72 hours post LAIV administration
Respiratory, thoracic and mediastinal disorders Cough	5.6% 27/478 • Number of events 27 • 72 hours post LAIV administration
Respiratory, thoracic and mediastinal disorders Wheezing	5.6% 27/478 • Number of events 27 • 72 hours post LAIV administration

Additional Information

Dr Paul Turner

Imperial College London

Phone: +44 20 3312 7754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place