## Protocol Section
### Identification Module
**NCT ID:** NCT01202279

**Acronym:** Wait and See

**Brief Title:** Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment

#### Organization Study ID Info
**ID:** 2009-MUCD-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Reckitt Benckiser LLC
### Status Module
#### Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-12-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-11-04

**Type:** ESTIMATED

**Results First Submit Date:** 2011-04-04

**Results First Submit QC Date:** 2012-10-04

#### Start Date
**Date:** 2009-10

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2010-09-15
**Type:** ESTIMATED
**Study First Submit Date:** 2010-09-13
**Study First Submit QC Date:** 2010-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Reckitt Benckiser Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

### Conditions Module

**Conditions:**

- Acute Upper Respiratory Track Infection

**Keywords:**

- Acute Upper Respiratory Track Infection Who Seek Treatment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1179

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days

**Intervention Names:**

- Drug: Guaifenesin

**Label:** Mucinex D

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Placebo given bid with a full glass of water for 7 days

**Intervention Names:**

- Device: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mucinex D

**Description:** 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days

**Name:** Guaifenesin

**Other Names:**

- Mucinex D

- Mucinex

- Pseudoephedrine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo bid for 7 days

**Name:** Placebo

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of patients who received an antibiotic

**Measure:** Antibiotic Sparing

**Time Frame:** Day 7

**Description:** WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.

**Measure:** Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).

**Time Frame:** Baseline and 7 Days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days

Exclusion Criteria:

* patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mesa

**Country:** United States

**Facility:** Clinical Research Advantage, Inc.

**State:** Arizona

**Zip:** 85203

**Location 2:**

**City:** Carmichael

**Country:** United States

**Facility:** Med Center

**State:** California

**Zip:** 95608

**Location 3:**

**City:** Fresno

**Country:** United States

**Facility:** Research Center of Fresno, 3636 N. First Street, Suite 141

**State:** California

**Zip:** 93726

**Location 4:**

**City:** San Luis Obispo

**Country:** United States

**Facility:** Coastal Medical Research Group, Inc., 47 Santa Rosa Street

**State:** California

**Zip:** 93405

**Location 5:**

**City:** New London

**Country:** United States

**Facility:** Coastal Connecticut Research, LLC, 342 Montauk Avenue

**State:** Connecticut

**Zip:** 06320

**Location 6:**

**City:** Newark

**Country:** United States

**Facility:** Glasgow Family Practice

**State:** Delaware

**Zip:** 19702

**Location 7:**

**City:** Morton

**Country:** United States

**Facility:** Koch Family Medicine, 81A E. Queenwood Road

**State:** Illinois

**Zip:** 61550

**Location 8:**

**City:** Erlanger

**Country:** United States

**Facility:** Sterling Research Group, Ltd., 650 Sprucewood Lane

**State:** Kentucky

**Zip:** 41018

**Location 9:**

**City:** Reisterstown

**Country:** United States

**Facility:** Clinical Associates Research, 750 Main Street, Suite 310

**State:** Maryland

**Zip:** 21136

**Location 10:**

**City:** Taylor

**Country:** United States

**Facility:** Park Place Family Practice & Internal Medicine

**State:** Michigan

**Zip:** 48180

**Location 11:**

**City:** Bloomfield

**Country:** United States

**Facility:** Immedicenter

**State:** New Jersey

**Zip:** 07003

**Location 12:**

**City:** High Point

**Country:** United States

**Facility:** Peters Medical Research

**State:** North Carolina

**Zip:** 27262

**Location 13:**

**City:** Salisbury

**Country:** United States

**Facility:** (Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research

**State:** North Carolina

**Zip:** 28144

**Location 14:**

**City:** Columbus

**Country:** United States

**Facility:** Parsons Avenue Medical Clinic

**State:** Ohio

**Zip:** 43207

**Location 15:**

**City:** Enid

**Country:** United States

**Facility:** Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B

**State:** Oklahoma

**Zip:** 73703

**Location 16:**

**City:** Ashland

**Country:** United States

**Facility:** Integrated Medical Research, PC

**State:** Oregon

**Zip:** 97520

**Location 17:**

**City:** Harleysville

**Country:** United States

**Facility:** Harleysville Medical Associates, 176 Main Street

**State:** Pennsylvania

**Zip:** 19438

**Location 18:**

**City:** Johnstown

**Country:** United States

**Facility:** Kastelic MD & Associates, 322 Warren Street, Suite 300

**State:** Pennsylvania

**Zip:** 15905

**Location 19:**

**City:** Penndel

**Country:** United States

**Facility:** Durham Physicians, P.C.

**State:** Pennsylvania

**Zip:** 19047

**Location 20:**

**City:** Mount Pleasant

**Country:** United States

**Facility:** Palmetto Medical Research, 180 Wingo Way, Suite 203

**State:** South Carolina

**Zip:** 29464

**Location 21:**

**City:** Bristol

**Country:** United States

**Facility:** TriCities Medical Research

**State:** Tennessee

**Zip:** 37620

**Location 22:**

**City:** Plano

**Country:** United States

**Facility:** Village Health Partners

**State:** Texas

**Zip:** 75024

**Location 23:**

**City:** Virginia Beach

**Country:** United States

**Facility:** Independence Family Medicine, 813 Independence Blvd., Suite A

**State:** Virginia

**Zip:** 23455

**Location 24:**

**City:** Winchester

**Country:** United States

**Facility:** Amherst Family Practice, 1867 Amherst Street

**State:** Virginia

**Zip:** 22601

### References Module

#### References

**Citation:** Septimus EJ, Albrecht HH, Solomon G, Shea T, Guenin EP. Extended-Release Guaifenesin/Pseudoephedrine Hydrochloride for Symptom Relief in Support of a Wait-and-See Approach for the Treatment of Acute Upper Respiratory Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Study. Curr Ther Res Clin Exp. 2017 Apr 28;84:54-61. doi: 10.1016/j.curtheres.2017.04.004. eCollection 2017.

**PMID:** 28761581

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

### Intervention Browse Module - Ancestors

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000014663

- Term: Nasal Decongestants

- ID: D000014662

- Term: Vasoconstrictor Agents

- ID: D000013566

- Term: Sympathomimetics

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005100

- Term: Expectorants

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000001067

- Term: Appetite Depressants

- ID: D000019440

- Term: Anti-Obesity Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: AnObAg

- Name: Anti-Obesity Agents

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M7966

- Name: Ephedrine

- Relevance: LOW

- As Found: Unknown

- ID: M27586

- Name: Pseudoephedrine

- Relevance: HIGH

- As Found: LAR

- ID: M13570

- Name: Phenylpropanolamine

- Relevance: HIGH

- As Found: Graph

- ID: M9238

- Name: Guaifenesin

- Relevance: HIGH

- As Found: Graph

- ID: M186319

- Name: Chlorpheniramine, phenylpropanolamine drug combination

- Relevance: HIGH

- As Found: Graph

- ID: M5985

- Name: Chlorpheniramine

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17410

- Name: Nasal Decongestants

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8243

- Name: Expectorants

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M4379

- Name: Appetite Depressants

- Relevance: LOW

- As Found: Unknown

- ID: M21396

- Name: Anti-Obesity Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000010665

- Term: Phenylpropanolamine

- ID: D000054199

- Term: Pseudoephedrine

- ID: D000006140

- Term: Guaifenesin

- ID: C000083542

- Term: Chlorpheniramine, phenylpropanolamine drug combination

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Mucinex D

**Description:** Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days

**ID:** EG000

**Other Num Affected:** 37

**Other Num at Risk:** 593

**Serious Number At Risk:** 593

**Title:** Mucinex D

**Group ID:** EG001

**Title:** Placebo

**Description:** Placebo given bid with a full glass of water for 7 days

**ID:** EG001

**Other Num Affected:** 21

**Other Num at Risk:** 591

**Serious Number At Risk:** 591

**Title:** Placebo

**Frequency Threshold:** 0

#### Other Events

**Term:** Nervousness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (12.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (12.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (12.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (12.0)

**Time Frame:** Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 591

**Group ID:** BG001

**Value:** 588

**Group ID:** BG002

**Value:** 1179

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mucinex D

**Description:** Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo given bid with a full glass of water for 7 days

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 575

#### Measurement

**Group ID:** BG001

**Value:** 575

#### Measurement

**Group ID:** BG002

**Value:** 1150

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.7

**Value:** 37.4

#### Measurement

**Group ID:** BG001

**Spread:** 13.7

**Value:** 38.8

#### Measurement

**Group ID:** BG002

**Spread:** 13.7

**Value:** 38.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 395

#### Measurement

**Group ID:** BG001

**Value:** 404

#### Measurement

**Group ID:** BG002

**Value:** 799

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 196

#### Measurement

**Group ID:** BG001

**Value:** 184

#### Measurement

**Group ID:** BG002

**Value:** 380

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 591

#### Measurement

**Group ID:** BG001

**Value:** 588

#### Measurement

**Group ID:** BG002

**Value:** 1179

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalRequests@rb.com
**Organization:** Reckitt Benckiser
**Phone:** 855.966.5483
**Title:** Kim Clark
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.025
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Fisher Exact
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.022
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 121
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.71
- **Upper Limit:** 
- **Value:** -14.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.99
- **Upper Limit:** 
- **Value:** -13.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of patients who received an antibiotic
**Parameter Type:** NUMBER
**Population Description:** Per Protocol Population using Fishers Exact Test.
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Antibiotic Sparing
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
**ID:** OG000
**Title:** Mucinex D
##### Group
**Description:** Placebo given bid with a full glass of water for 7 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and 7 Days
**Title:** Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
**ID:** OG000
**Title:** Mucinex D
##### Group
**Description:** Placebo given bid with a full glass of water for 7 days
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
**ID:** FG000
**Title:** Mucinex D
#### Group
**Description:** Placebo given bid with a full glass of water for 7 days
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 10
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 10
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** study compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 591
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 588
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 554
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 561
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
**Recruitment Details:** Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.
**Has Results:** True