Hypertonic Saline Nasal Irrigation and Gargling for the Common Cold.

NCT02438579 | Completed

• 2 other identifiers: 13/SS/007910-303
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Viral upper respiratory tract infections (URTI), one of the commonest infection faced by humans, have a significant impact on individuals, families, health service and economy. Though rhinoviruses are called the "common cold virus", numerous viruses can cause URTI. Hence virus specific remedy for URTI is impractical. There are currently no evidence-based interventions that reduce the severity, symptom duration or viral shedding. Preliminary evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the duration of symptoms. With this pilot randomised controlled trial (RCT), the investigators aim to assess the feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention. This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured by a validated symptom score. A questionnaire based participant feedback will help assess intervention and trial procedures. This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost intervention that has the potential of substantial health and societal benefits.

Conditions

Common Cold; Upper Respiratory Tract Infections

Keywords

Hypertonic saline; nasal irrigation; gargling; URTI

Outcome Measures

Primary Outcomes (1)

• What is the recruitment rate?

  A standard accrual plot will be produced, a plot of number of participants recruited in each week and the recruitment rate will be expressed as the average number of participants recruited per week over the duration of the study period. A table showing number of participants recruited by site will also be produced.

  6 months

Secondary Outcomes (6)

• What is the rate of sample return within the two arms?

  6 months

• What is the rate of diary completion within the two arms?

  6 months

• Do the participants comply with the intervention regime?

  6 months

• What are the participant views on acceptability?

  6 months

• Is there a difference between arms in their quality-of-life?

  6 months

Study Arms (2)

Nasal Irrigation & Gargling

EXPERIMENTAL

Videos on how to collect nasal swabs, prepare and perform hypertonic saline nasal irrigation and gargling (HSNIG) are shown. A nasal swab is collected. Participant chooses the highest concentration of hypertonic saline he/she is comfortable with (from 1.5, 2.0, 2.5 and 3.0%) and performs HSNIG under observation. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.

Other: Nasal Irrigation & Gargling

Control

NO INTERVENTION

The control group are advised to manage the URTI as they normally do. A video on how to collect nasal swabs is shown. A nasal swab is collected. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.

Interventions

Nasal Irrigation & Gargling OTHER

Participants are advised to perform the intervention as frequently as required (expected frequency around 6 times a day for the first two days, reducing in frequency from day 3 as symptoms improve).

Nasal Irrigation & Gargling

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of upper respiratory tract infection (URTI)
• Within 48 hours of onset

You may not qualify if:

• Onset of URTI \>48 hours
• On antibiotics
• Pregnancy
• History of chronic illness or immunosuppression
• Allergic rhinitis
• Unable to perform nasal irrigation and gargling
• Taking part in another medical trial

Sponsors & Collaborators

• NHS Lothian: lead
• University of Edinburgh: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76.

  PMID: 19674476 BACKGROUND

MeSH Terms

Conditions

Common Cold; Respiratory Tract Infections

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Sandeep Ramalingam, PhD, FRCPath

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Virologist

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: May 8, 2015
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

GB (1)