To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold

NCT03005067 | Completed Phase 2 Results

• 1 other identifier: 205684
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 24

Brief Summary

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)

  The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.

  Up to Day 4 (Day 1 to 4)

Secondary Outcomes (3)

• Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)

  Up to Day 7 (Day 1 to 7)

• Average Total Symptom Score Over Days 1-4 (ATSS1-4)

  Up to Day 4 (Day 1 to 4)

• Average Total Symptom Score Over Days 1-7 (ATSS1-7)

  Up to Day 7 (Day 1 to 7)

Study Arms (2)

Carbomer 980 (1146A)

EXPERIMENTAL

Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg.

Drug: Carbomer 980 (1146A)

Placebo

PLACEBO COMPARATOR

Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL.

Other: Placebo

Interventions

Carbomer 980 (1146A) DRUG

Test product containing carbomer 980 gel

Carbomer 980 (1146A)

Placebo OTHER

Reference product containing vehicle without carbomer 980 gel

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Aged between 18 to 75 years inclusive.
• Male or female.
• Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination.
• Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.
• Investigator confirmed diagnosis of symptomatic common cold with an onset of less than 48 hours prior to randomization. Symptomatic common cold is defined as TSS \> 9 AND a score \>1 for at least one of the following symptoms: sore throat, runny nose, or blocked nose.

You may not qualify if:

• Women who have a positive urine pregnancy test.
• Women who are breast-feeding.
• During the entire study (Screening - last participant visit):
• A. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study.
• B. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
• C. Nasal surgery or sinus surgery within the previous year.
• D. Any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers).
• E. Clinically relevant abnormal physical findings which, in the opinion of the Investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
• F. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other diseases at screening that would interfere with the study in the opinion of the Investigator.
• G. Participants with seasonal allergic rhinitis if randomization occurs during their expected allergy season or perennial allergic rhinitis.
• H. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation.
• I. An inability to comprehend and satisfactorily use the measurement instruments as determined by the study sites staff on screening.
• J. Participants with a fever \> 38°C (100.4°F).
• K. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and pain in muscle/joints for at least 1 dose per week on average over the past 6 months).
• Known or suspected intolerance or hypersensitivity to any of the study medications, excipients or investigational device material or to medications of similar chemical classes, any history of drug hypersensitivity or other significant allergic diathesis that could affect study participation and known or suspected contraindications, including history of allergy or photosensitivity to study medication/s.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Birmingham, Alabama, 35211, United States

Location

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Mesa, Arizona, 85206, United States

Location

GSK Investigational Site

Vista, California, 92083, United States

Location

GSK Investigational Site

Centennial, Colorado, 80112, United States

Location

GSK Investigational Site

Littleton, Colorado, 80128, United States

Location

GSK Investigational Site

Pinellas Park, Florida, 33781, United States

Location

GSK Investigational Site

Chicago, Illinois, 60602, United States

Location

GSK Investigational Site

Council Bluffs, Iowa, 51503, United States

Location

GSK Investigational Site

Edina, Minnesota, 55435, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Elkhorn, Nebraska, 68022, United States

Location

GSK Investigational Site

Fremont, Nebraska, 68025, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68144, United States

Location

GSK Investigational Site

Vineland, New Jersey, United States

Location

GSK Investigational Site

Akron, Ohio, 44311, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45249, United States

Location

GSK Investigational Site

Hatboro, Pennsylvania, 19040, United States

Location

GSK Investigational Site

Anderson, South Carolina, 29621, United States

Location

GSK Investigational Site

Dallas, Texas, 75234, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Murray, Utah, 84123, United States

Location

GSK Investigational Site

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Common Cold

Interventions

carbomer

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 29, 2016
• Study Start: December 29, 2016
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-04

Locations

US (24)