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Safety of Nasal Influenza Immunisation in Children With Asthma (SNIFFLE-4)

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ClinicalTrials.gov Identifier: NCT02866942
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : April 26, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Public Health England
Information provided by (Responsible Party):
Paul Turner, Imperial College London

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Asthma
Intervention Drug: Administration of Live attenuated influenza vaccine (LAIV)
Enrollment 479
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Asthma
Hide Arm/Group Description

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Administration of Live attenuated influenza vaccine (LAIV)

Period Title: Overall Study
Started 479
Completed 478
Not Completed 1
Reason Not Completed
Invalid consent             1
Arm/Group Title Asthma
Hide Arm/Group Description

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Administration of Live attenuated influenza vaccine (LAIV)

Overall Number of Baseline Participants 478
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants
<=18 years
476
  99.6%
Between 18 and 65 years
2
   0.4%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 478 participants
9.3
(2.0 to 18.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants
Female
190
  39.7%
Male
288
  60.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 478 participants
478
British Thoracic Society (BTS) Treatment Step 4+   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants
229
  47.9%
[1]
Measure Description:

STEP 4+, assigned as "persistent poor control" in asthma, is defined as:

  • requiring high dose inhaled corticosteroids (>800 micrograms beclomethasone equivalent) per day, and/or
  • 3+ preventer medications
1.Primary Outcome
Title Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire
Hide Description

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.

Time Frame 4 weeks post LAIV
Hide Outcome Measure Data
Hide Analysis Population Description
4 week follow-up data available in 319/478 participants
Arm/Group Title Asthma
Hide Arm/Group Description:

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Administration of Live attenuated influenza vaccine (LAIV)

Overall Number of Participants Analyzed 319
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement >= MID
28
   8.8%
No change
254
  79.6%
Deterioration >= MID
37
  11.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asthma
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV
Hide Description

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

Time Frame Up to 4 weeks post LAIV administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asthma
Hide Arm/Group Description:

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Administration of Live attenuated influenza vaccine (LAIV)

Overall Number of Participants Analyzed 319
Measure Type: Count of Participants
Unit of Measure: Participants
47
  14.7%
Time Frame 72 hours post LAIV administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Asthma
Hide Arm/Group Description

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Administration of Live attenuated influenza vaccine (LAIV)

All-Cause Mortality
Asthma
Affected / at Risk (%)
Total   0/478 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Asthma
Affected / at Risk (%) # Events
Total   4/478 (0.84%)    
Respiratory, thoracic and mediastinal disorders   
Wheezing  1  4/478 (0.84%)  4
1
Term from vocabulary, Internal PHE categor
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Asthma
Affected / at Risk (%) # Events
Total   150/478 (31.38%)    
General disorders   
Malaise  1  42/478 (8.79%)  42
Respiratory, thoracic and mediastinal disorders   
Rhinitis  1  54/478 (11.30%)  54
Cough  1  27/478 (5.65%)  27
Wheezing  1  27/478 (5.65%)  27
1
Term from vocabulary, Internal PHE categor
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Paul Turner
Organization: Imperial College London
Phone: +44 20 3312 7754
EMail: p.turner@imperial.ac.uk
Layout table for additonal information
Responsible Party: Paul Turner, Imperial College London
ClinicalTrials.gov Identifier: NCT02866942     History of Changes
Other Study ID Numbers: 16SM3348
2016-002352-24 ( EudraCT Number )
First Submitted: August 4, 2016
First Posted: August 15, 2016
Results First Submitted: February 14, 2019
Results First Posted: April 26, 2019
Last Update Posted: May 10, 2019