Trial Outcomes & Findings for Prophylactic Efficacy of Relenza Against Influenza A and B (NCT NCT01156701)

NCT ID: NCT01156701

Last Updated: 2017-05-30

Results Overview

The frequency of influenza among the four cohorts was measured.

• Recruitment status: COMPLETED
• Target enrollment: 171705 participants
• Primary outcome timeframe: 2006-2009
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	Cohort 1: Prophylaxis With Untreated Index Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Overall Study STARTED	257	1007	163716	6725
Overall Study COMPLETED	257	1007	163716	6725
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Efficacy of Relenza Against Influenza A and B

Baseline characteristics by cohort

Measure	All Patients Included in the Analysis n=171705 Participants All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
Age, Customized 5-14 years	47670 Participants n=5 Participants
Age, Customized 15-44 years	85640 Participants n=5 Participants
Age, Customized 45-64 years	37119 Participants n=5 Participants
Age, Customized >=65 years	1276 Participants n=5 Participants
Sex: Female, Male Female	84162 Participants n=5 Participants
Sex: Female, Male Male	87543 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2006-2009

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of influenza among the four cohorts was measured.

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Influenza Influenza	3 patients	10 patients	2539 patients	93 patients
Number of Patients With Influenza No Influenza	254 patients	997 patients	161177 patients	6632 patients

SECONDARY outcome

Timeframe: 2006-2009

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of asthma among the four cohorts was measured.

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Asthma Asthma	1 patients	5 patients	1488 patients	54 patients
Number of Patients With Asthma No Asthma	256 patients	1002 patients	162228 patients	6671 patients

SECONDARY outcome

Timeframe: 2006-2009

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of pneumonia among the four cohorts was measured..

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Pneumonia Pneumonia	2 patients	1 patients	541 patients	16 patients
Number of Patients With Pneumonia No Pneumonia	255 patients	1006 patients	163175 patients	6709 patients

SECONDARY outcome

Timeframe: 2006-2009

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of bronchitis among the four cohorts was measured.

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Bronchitis Bronchitis	8 patients	15 patients	2572 patients	96 patients
Number of Patients With Bronchitis No Bronchitis	249 patients	992 patients	161144 patients	6629 patients

SECONDARY outcome

Timeframe: 2006-2009

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of any respiratory diagnosis among the four cohorts was measured.

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Any Respiratory Diagnosis Respiratory Diagnosis	16 patients	50 patients	10166 patients	420 patients
Number of Patients With Any Respiratory Diagnosis No Respiratory Diagnosis	241 patients	957 patients	153550 patients	6305 patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Patients With Respiratory Outcomes Influenza	3 patients	10 patients	2539 patients	93 patients
Number of Patients With Respiratory Outcomes Asthma	1 patients	5 patients	1488 patients	54 patients
Number of Patients With Respiratory Outcomes Chronic obstructive pulmonary disease (COPD)	0 patients	0 patients	153 patients	3 patients
Number of Patients With Respiratory Outcomes Exacerbation of COPD	0 patients	0 patients	34 patients	0 patients
Number of Patients With Respiratory Outcomes Bronchospasm	0 patients	0 patients	110 patients	5 patients
Number of Patients With Respiratory Outcomes Pneumonia	2 patients	1 patients	541 patients	16 patients
Number of Patients With Respiratory Outcomes Bronchitis	8 patients	15 patients	2572 patients	96 patients
Number of Patients With Respiratory Outcomes Sinusitis	1 patients	20 patients	2708 patients	140 patients
Number of Patients With Respiratory Outcomes Otitis media	2 patients	4 patients	1582 patients	64 patients
Number of Patients With Respiratory Outcomes Any of the above	16 patients	50 patients	10166 patients	420 patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).

The frequency of hospitalization and death in the study population was analyzed.

Outcome measures

Measure	Cohort 1: Prophylaxis With Untreated Index n=257 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 2: Prophylaxis With Treated Index n=1007 Participants Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 3: Untreated With Untreated Index n=16371 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)	Cohort 4: Untreated With Treated Index n=6725 Participants Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
Number of Participants Experiencing Hospitalization or Death Due to Influenza Hospitalization	0 patients	6 patients	1063 patients	41 patients
Number of Participants Experiencing Hospitalization or Death Due to Influenza Death	0 patients	0 patients	4 patients	0 patients

Adverse Events

Cohort 1: Prophylaxis With Untreated Index

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: Prophylaxis With Treated Index

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Untreated With Untreated Index

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 4: Untreated With Treated Index

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER