Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01119534
Eligibility Criteria:
Inclusion Criteria:
* Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;
* Patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.
* Patients with acute respiratory disease of upper respiratory viral diseases (URI);
* Patients with productive cough;
* Clinical picture of URI defined by the doctor that started less than 48 hours.
Exclusion Criteria:
* Patients being treated with antibiotics;
* Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).
* Patients with non-productive cough;
* Treatment with immunosuppressive drugs;
* Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
* Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;
* Patients with serious diseases;
* Patients who require multidrug treatment;
* Presence of other concomitant pulmonary diseases
* History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
* Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;
* Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;
* Patients with severe dysfunction of the hepatorenal function;
* Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;
* Patients with blood cell count suggestive of bacterial infection;
* Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT01119534
Study Brief:
Protocol Section:
NCT01119534