Prevention and therapy of respiratory disease in children using nasal sprays

Completed

Conditions: Early symptoms of upper respiratory tract infection (URTI) in children
Respiratory
Acute upper respiratory infection, unspecified

Registration Number: ISRCTN52519535

Lead Sponsor: St. Anna Children?s Hospital (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Age < 18 years
2. Age > 1 years
3. Parents had given informed consent, and received a copy of signed consent form prior to any study related procedures
4. Symptoms of Upper Respiratory Tract Infection (URTI), such as rhinitis/nasal obstruction/sneezing or cough or sore throat or otitis
5. Subjects or their parents considered that the subjects were in an early stage of a common cold with symptoms no more than 36 hours duration
6. Subjects had a symptom score of at least 1 and no more than 9 of sum of severity scores on entry to the study. The score was calculated by summing 8 symptom scores (headache, muscle ache, chilliness, sore throat, nasal obstruction, nasal discharge, cough, and sneezing) with each item rated 0 = absent, 1 = mild, 2 = moderate, 3 = severe
7. Subjects or their parents agreed to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 7
8. The following were specifically disallowed:
8.1. Antihistamines, decongestants, antitussives, combination cold products, antivirals, oral or nasal steroids, all nasal sprays, any cold-directed herbal treatment (e.g. andrographis, echinacea, garlic, ginger, ginseng, pelargonium, propolis), and any supplement or lozenge containing = 10 mg zinc or = 100mg vitamin C).
8.2. Eating food cooked with garlic or ginger was allowed. Use of a daily multivitamin was allowed.
8.3. Analgesics, especially nonsteroidal anti-inflammatory drugs, were discouraged. Subjects with pain requiring medication were requested to use acetaminophen (paracetamol) and to record such use for consideration in statistical analysis.

Exclusion Criteria

1. No informed consent
2. Known hypersensitivity or allergy to any component of the test product
3. Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that was considered by the investigator as a reason for exclusion
4. Severe nasal septal deviation or other noninfectious condition that could have caused nasal obstruction
5. A history of any nasal or sinus surgery in the past that in the opinion of the investigator had might influenced symptom scores
6. Current medication other than oral contraception, that was considered by the investigator as a reason for exclusion e.g. systemic steroids or intranasal medication
7. Recent treatment of common cold that in the opinion of the investigator might influence symptom scores (e.g. antihistamines, decongestants, antitussives, combination cold products, antiviral, steroids, all nasal sprays, any cold-directed herbal treatment, and any supplement or lozenge containing = 10 mg zinc or = 100 mg vitamin C)
8. An unrelated infection that in the opinion of the investigator might influence the symptom scores (gastrointestinal infection, other viral diseases such as measles, mumps)
9. The subject was related to any study personnel, or had any other close ties or conflicts of interest with the research team or the study sponsor
10. The subject had received any investigational drug or had participated in a clinical trial within 4 weeks of entry to this study
11. The subject had a clinically significant disease that could have interfered with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions included immune deficiency, autoimmune disease, and substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease. A history of allergic rhinitis with current eye or nose itching or sneezing, chronic obstructive pulmonary disease with current cough will also be exclusions. A symptomatic disease such as elevated blood pressure or cholesterol had not to be a reason for exclusion.