Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

• Sponsor: Amarillo Biosciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00895947
• Collaborator: Department of Health, Western Australia (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infections	Drug: interferon-alpha; Other: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interferon-alpha 150 international units of interferon-alpha	Drug: interferon-alpha; a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks; Other Names: IFN-alpha lozenge
Placebo Comparator: placebo placebo lozenges	Other: placebo; placebo lozenges for oral dissolution taken once daily for 16 weeks; Other Names: Maltose lozenge

Outcome Measures

Primary Outcome Measures

1. Frequency of Influenza-like Illness [16 weeks]

   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).

Secondary Outcome Measures

1. Symptom Incidence/Severity [16 weeks]

   Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly

2. Impact of Cold/Flu Symptoms [16 weeks]

   Number 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.

3. Negative Events Related to Cold/Flu Symptoms [16 weeks]

   Number 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

4. Incidence/Severity of Viral Respiratory Infections [16 weeks]

   Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or non-pregnant female

• Females of child-bearing potential must practice a medically accepted form of birth control

Exclusion Criteria:

• Currently exhibiting an acute upper respiratory tract infection

• history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)

• any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)

• any condition requiring regular treatment with antihistamines, analgesics or antipyretics

• known infection with HIV, hepatitis B virus or hepatitis C virus

• any other serious, uncontrolled disease

• any active infections requiring use of antibiotic or antiviral drugs

• non-ambulatory status

• suspected drug or alcohol abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Western Australia	Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

• Amarillo Biosciences, Inc.
• Department of Health, Western Australia

Investigators

• Principal Investigator: David Smith, PhD, Path West Laboratory Medicine WA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amarillo Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT00895947
• Other Study ID Numbers: 2008-113
• First Posted: May 8, 2009
• Last Update Posted: Sep 16, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Amarillo Biosciences, Inc.: Prophylaxis; Treatment; Symptoms; Winter Colds and Flu
• Additional relevant MeSH terms: Respiratory Tract Infections; Interferons; Interferon-alpha

Study Results

Participant Flow

Recruitment Details	A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.
Pre-assignment Detail	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.

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Period Title: Overall Study
STARTED	100	100
COMPLETED	88	90
NOT COMPLETED	12	10

Baseline Characteristics

Arm/Group Title	Interferon-alpha	Placebo	Total
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge	Total of all reporting groups
Overall Participants	100	100	200
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	95 95%	91 91%	186 93%
>=65 years	5 5%	9 9%	14 7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (14.4)	47.3 (13.2)	46.2 (14.2)
Sex: Female, Male (Count of Participants)
Female	70 70%	66 66%	136 68%
Male	30 30%	34 34%	64 32%
Region of Enrollment (participants) [Number]
Australia	100 100%	100 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Frequency of Influenza-like Illness
Description	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).
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
Overall	54 54%	62 62%
Age 50 and over	16 16%	28 28%
Age under 50	38 38%	34 34%
Seasonal flu vaccine, yes	16 16%	36 36%
Seasonal flu vaccine, no	38 38%	26 26%
Gender, Male	11 11%	22 22%
Gender, Female	43 43%	40 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments	Overall comparison of treatment groups for incidence of ILI
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	Comparision of ILI incidence in subjects age 50 and older at baseline.
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments	Comparison of ILI in subjects age < 50 at baseline
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments	Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment
	Method	Chi-squared
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Comparison of ILI incidence in male subjects
	Method	Chi-squared
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments	Comparison of ILI incidence in female subjects
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Symptom Incidence/Severity
Description	Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
any cold/flu symptoms	86 86%	92 92%
moderate to severe feverishness	12 12%	24 24%
moderate to severe head congestion	23 23%	36 36%
moderate to severe sore throat	27 27%	39 39%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments	Proportion of subjects reporting any cold/flu symptoms during treatment
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Proportion of subjects reporting moderate to severe feverishness
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	Proportion of subjects reporting moderate to severe head congestion
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments	Proportion of subjects reporting moderate to severe sore throat
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Impact of Cold/Flu Symptoms
Description	Number 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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
think clearly	53 53%	59 59%
sleep well	54 54%	64 64%
breathe easily	58 58%	61 61%
walk, climb stairs and exercise	44 44%	49 49%
perform daily activities	46 46%	54 54%
work outside the home	43 43%	51 51%
work inside the home	42 42%	51 51%
interact with others	41 41%	50 50%
live personal life	44 44%	51 51%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.39
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities
	Method	Chi-squared
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home
	Method	Chi-squared
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home
	Method	Chi-squared
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others
	Method	Chi-squared
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments	Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Negative Events Related to Cold/Flu Symptoms
Description	Number 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
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
felt sick	62 62%	65 65%
missed work	32 32%	33 33%
visited the doctor	16 16%	16 16%
visited the pharmacy	34 34%	30 30%
took cold/flu medication	57 57%	65 65%
skipped a planned activity	46 46%	45 45%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	Proportion of subjects in each group reporting one or more days they felt sick
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	Proportion of subjects in each group reporting one or more days they missed work
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments	Proportion of subjects in each group reporting one or more days they visited the doctor
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	Proportion of subjects in each group reporting one or more days they visited the pharmacy
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments	Proportion of subjects in each group reporting one or more days they took cold/flu medication
	Method	Chi-squared
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments	Proportion of subjects in each group reporting one or more days they skipped a planned activity
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Incidence/Severity of Viral Respiratory Infections
Description	Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
incidence of viral respiratory infection	20 20%	23 23%
moderate/severe viral respiratory infection	5 5%	16 16%
moderate/severe influenza infection	1 1%	4 4%
moderate/severe non-influenza infection	4 4%	11 11%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments	Proportion of subjects in each group with a confirmed viral respiratory infection
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	Proportion of subjects in each group with a moderate/severe viral respiratory infection
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Proportion of subjects in each group with a moderate/severe influenza infection
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza
	Method	Chi-squared
	Comments

6. Post-Hoc Outcome

Title	Acute Respiratory Illness
Description	Number 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."
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interferon-alpha	Placebo
Arm/Group Description	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	200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Measure Participants	99	99
all acute respiratory illness (ARI)	83 83%	86 86%
moderate/severe ARI	41 41%	54 54%
moderate/severe febrile ARI	12 12%	24 24%
moderate/severe afebrile ARI	35 35%	31 31%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	Proportion of subjects meeting the definition of acute respiratory illness during treatment
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Interferon-alpha, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments	Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Interferon-alpha		Placebo
Arm/Group Description	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		200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
All Cause Mortality
	Interferon-alpha		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Interferon-alpha		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/99 (1%)		1/99 (1%)
Surgical and medical procedures
appendectomy	0/99 (0%)	0	1/99 (1%)	1
hemorroidectomy	1/99 (1%)	1	0/99 (0%)	0
Other (Not Including Serious) Adverse Events
	Interferon-alpha		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/99 (30.3%)		33/99 (33.3%)
Gastrointestinal disorders
diarrhea	14/99 (14.1%)	20	9/99 (9.1%)	12
nausea	5/99 (5.1%)	5	6/99 (6.1%)	7
General disorders
fatigue	4/99 (4%)	5	8/99 (8.1%)	9
Musculoskeletal and connective tissue disorders
back pain	4/99 (4%)	4	6/99 (6.1%)	8
Nervous system disorders
headache	11/99 (11.1%)	20	10/99 (10.1%)	14
migraine	4/99 (4%)	4	5/99 (5.1%)	10
Respiratory, thoracic and mediastinal disorders
hay fever	6/99 (6.1%)	8	13/99 (13.1%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.