Common Treatments for Common Colds: A Pilot Study

Not Applicable

Completed

• Conditions: Common cold and acute rhinosinusitus; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000686202
• Lead Sponsor: Dr Deborah Askew

Brief Summary

Objective: A pilot study to evaluate the efficacy of isotonic saline nasal spray plus usual treatment, compared to usual treatment alone, for decreasing the duration and severity of symptoms of acute upper respiratory tract infections. Study Design: Single-blinded randomised controlled trial. Methods: patients presenting to general practice with symptoms of acute upper respiratory tract infections (malaise, cough, sore throat, and rhinorrhoea) were randomised to either receive usual treatment of analgesia, lozenges, and cold and flu medications alone, or usual treatment plus an isotonic saline nasal spray. Patients used their allocated treatment until their first day of wellness. Results were collected by standardised participant diaries, which recorded first day of wellness, daily symptom scores measured on a four-point scale, which treatments were used daily, mean days off work or school, return visits to general practice, and use of antibiotics. Results: Valid outcome data was available for 33 participants, 23 usual treatment and 10 saline treatment. Days to wellness for the saline group (mean=7.7) was less than for usual treatment (10.5), although this difference was not significantly different. There were no significant differences in symptom severity, return visits to GPs, days off work, or antibiotic use. Conclusions: It remains unknown whether isotonic nasal saline spray improves symptoms of acute URTI, possibly due to the small sample size of this study.However, in light of good theoretical rationale for use and other promising literature, future research is warranted. This study establishes an appropriate, transparent research methodology for future studies.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-11
• Study Completion: 2012-06-30
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

patients >= 2 years of age presenting to a participating General Practitioner (GP) with common cold with symptoms of runny nose, sore throat, sneezing, cough, lethargy etc, or acute rhinosinusitus. For inclusion, participants must have had symptoms for =5 days and =3 weeks.

Exclusion Criteria

Patients will not be eligible if they have known or suspected Chronic Obstructive Pulmonary Disease (COPD); have been, or wish to use steam inhalations; have anatomical abnormalities or physical impairment preventing compliance with study protocol; have cognitive impairment preventing informed consent; or are known to the GP as having other social or medical issues that preclude involvement in this study. Any patient who, subsequent to the recruitment consultation, receives a positive identification of pertussis infection (Whooping Cough) will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified