Trial Outcomes & Findings for Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu (NCT NCT00895947)
NCT ID: NCT00895947
Last Updated: 2011-09-16
Results Overview
Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
16 weeks
Results posted on
2011-09-16
Participant Flow
A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.
Two of 200 randomized subjects (one in each group) decided not to begin study treatment after enrollment, so only 198 subjects were evaluable for response.
Participant milestones
| Measure |
Interferon-alpha
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
88
|
90
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
Interferon-alpha
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Baseline characteristics by cohort
| Measure |
Interferon-alpha
n=100 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=100 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age Continuous
|
45.0 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
47.3 years
STANDARD_DEVIATION 13.2 • n=107 Participants
|
46.2 years
STANDARD_DEVIATION 14.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
100 participants
n=99 Participants
|
100 participants
n=107 Participants
|
200 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug
Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Frequency of Influenza-like Illness
Overall
|
54 participants
|
62 participants
|
|
Frequency of Influenza-like Illness
Age 50 and over
|
16 participants
|
28 participants
|
|
Frequency of Influenza-like Illness
Age under 50
|
38 participants
|
34 participants
|
|
Frequency of Influenza-like Illness
Seasonal flu vaccine, yes
|
16 participants
|
36 participants
|
|
Frequency of Influenza-like Illness
Seasonal flu vaccine, no
|
38 participants
|
26 participants
|
|
Frequency of Influenza-like Illness
Gender, Male
|
11 participants
|
22 participants
|
|
Frequency of Influenza-like Illness
Gender, Female
|
43 participants
|
40 participants
|
SECONDARY outcome
Timeframe: 16 weeksNumber of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Symptom Incidence/Severity
any cold/flu symptoms
|
86 participants
|
92 participants
|
|
Symptom Incidence/Severity
moderate to severe feverishness
|
12 participants
|
24 participants
|
|
Symptom Incidence/Severity
moderate to severe head congestion
|
23 participants
|
36 participants
|
|
Symptom Incidence/Severity
moderate to severe sore throat
|
27 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 16 weeksNumber of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Impact of Cold/Flu Symptoms
think clearly
|
53 participants
|
59 participants
|
|
Impact of Cold/Flu Symptoms
sleep well
|
54 participants
|
64 participants
|
|
Impact of Cold/Flu Symptoms
breathe easily
|
58 participants
|
61 participants
|
|
Impact of Cold/Flu Symptoms
walk, climb stairs and exercise
|
44 participants
|
49 participants
|
|
Impact of Cold/Flu Symptoms
perform daily activities
|
46 participants
|
54 participants
|
|
Impact of Cold/Flu Symptoms
work outside the home
|
43 participants
|
51 participants
|
|
Impact of Cold/Flu Symptoms
work inside the home
|
42 participants
|
51 participants
|
|
Impact of Cold/Flu Symptoms
interact with others
|
41 participants
|
50 participants
|
|
Impact of Cold/Flu Symptoms
live personal life
|
44 participants
|
51 participants
|
SECONDARY outcome
Timeframe: 16 weeksNumber of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Negative Events Related to Cold/Flu Symptoms
felt sick
|
62 participants
|
65 participants
|
|
Negative Events Related to Cold/Flu Symptoms
missed work
|
32 participants
|
33 participants
|
|
Negative Events Related to Cold/Flu Symptoms
visited the doctor
|
16 participants
|
16 participants
|
|
Negative Events Related to Cold/Flu Symptoms
visited the pharmacy
|
34 participants
|
30 participants
|
|
Negative Events Related to Cold/Flu Symptoms
took cold/flu medication
|
57 participants
|
65 participants
|
|
Negative Events Related to Cold/Flu Symptoms
skipped a planned activity
|
46 participants
|
45 participants
|
SECONDARY outcome
Timeframe: 16 weeksNumber of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Incidence/Severity of Viral Respiratory Infections
incidence of viral respiratory infection
|
20 participants
|
23 participants
|
|
Incidence/Severity of Viral Respiratory Infections
moderate/severe viral respiratory infection
|
5 participants
|
16 participants
|
|
Incidence/Severity of Viral Respiratory Infections
moderate/severe influenza infection
|
1 participants
|
4 participants
|
|
Incidence/Severity of Viral Respiratory Infections
moderate/severe non-influenza infection
|
4 participants
|
11 participants
|
POST_HOC outcome
Timeframe: 16 weeksNumber of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as "febrile" or "afebrile" depending on whether the subject reported the symptom of "feverishness."
Outcome measures
| Measure |
Interferon-alpha
n=99 Participants
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 Participants
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Acute Respiratory Illness
all acute respiratory illness (ARI)
|
83 participants
|
86 participants
|
|
Acute Respiratory Illness
moderate/severe ARI
|
41 participants
|
54 participants
|
|
Acute Respiratory Illness
moderate/severe febrile ARI
|
12 participants
|
24 participants
|
|
Acute Respiratory Illness
moderate/severe afebrile ARI
|
35 participants
|
31 participants
|
Adverse Events
Interferon-alpha
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon-alpha
n=99 participants at risk
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 participants at risk
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Surgical and medical procedures
appendectomy
|
0.00%
0/99 • 16 weeks
|
1.0%
1/99 • Number of events 1 • 16 weeks
|
|
Surgical and medical procedures
hemorroidectomy
|
1.0%
1/99 • Number of events 1 • 16 weeks
|
0.00%
0/99 • 16 weeks
|
Other adverse events
| Measure |
Interferon-alpha
n=99 participants at risk
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
|
Placebo
n=99 participants at risk
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.0%
4/99 • Number of events 4 • 16 weeks
|
6.1%
6/99 • Number of events 8 • 16 weeks
|
|
Gastrointestinal disorders
diarrhea
|
14.1%
14/99 • Number of events 20 • 16 weeks
|
9.1%
9/99 • Number of events 12 • 16 weeks
|
|
General disorders
fatigue
|
4.0%
4/99 • Number of events 5 • 16 weeks
|
8.1%
8/99 • Number of events 9 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
hay fever
|
6.1%
6/99 • Number of events 8 • 16 weeks
|
13.1%
13/99 • Number of events 17 • 16 weeks
|
|
Nervous system disorders
headache
|
11.1%
11/99 • Number of events 20 • 16 weeks
|
10.1%
10/99 • Number of events 14 • 16 weeks
|
|
Nervous system disorders
migraine
|
4.0%
4/99 • Number of events 4 • 16 weeks
|
5.1%
5/99 • Number of events 10 • 16 weeks
|
|
Gastrointestinal disorders
nausea
|
5.1%
5/99 • Number of events 5 • 16 weeks
|
6.1%
6/99 • Number of events 7 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place