Efficacy and Safety of Imuneks 10 mg Capsules in the Prophylaxis of Cold

NCT02807220 | Completed Phase 4

• 1 other identifier: ALPAN-KA001-16
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and safety of Imuneks 10 mg Capsules in the prophylaxis of cold and the maintenance of the good health state in 70 healthy subjects.

Conditions

Cold Symptoms

Keywords

Imuneks

Outcome Measures

Primary Outcomes (1)

• Prophylaxis of common cold and the change in blood lymphocyte, macrophage, neutrophil, eosinophil and monocyte counts from baseline values after first, third and sixth weeks after the oral use of the study medication.

  The baseline will be established by taking blood samples from the participants at their first visits. Each participant will report to the study staff any symptoms such as runny nose, cough, nasal congestion and sneezing during 6 weeks after administering the first dose of the study medication. Cold symptoms seen in the first week will be excluded from the evaluations as prophylactic effect will not be assessable before this period.

  6 weeks

Secondary Outcomes (2)

• The number of participants who took sick leaves.

  6 weeks

• Number of Participants with Adverse Events That Are Related to The Study Medication.

  6 weeks

Study Arms (1)

Imuneks 10mg

EXPERIMENTAL

Two capsules of the study drug every morning approximately two hours after breakfast for six weeks

Drug: Imuneks 10mg

Interventions

Imuneks 10mg DRUG

Two capsules of the study drug every morning approximately two hours after breakfast for six weeks

Also known as: micronized Beta-1,3/1,6-D-glucan

Imuneks 10mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physically and mentally healthy as judged by means of a medical and laboratory standard
• the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial)
• life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable
• body temperature, pulse rate, blood pressure, 12 lead ECG should be normal/acceptable.
• physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Iymph nodes, skin, and neurological/psychiatric) should be normal/acceptable
• laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, glucose, creatinine, BUN, uric acid, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab; urine examination: urine pH, protein, glucose, ketones, blood, Ieukocytes, bilirubin, nitrites and sediment) should be normal/acceptable.
• normal body weight in relation to height and age according to weight(kg) BMI = (accepted range 18.5 and30 kg/m2) height (m)2
• subjects must be competent to sign and have signed a consent form before study entry

You may not qualify if:

• acute or chronic upper airways disease, chronic cough, chronic rhinitis (e.g. allergic rhinitis) or asthma,
• vaccination against influenza or swine flu
• within 21 days before the study start, suspected swine flu or influenza, body temperature 38 0C,
• pregnancy or nursing,
• use of immunosuppressant, stimulants or common cold therapeutics,
• bacterial tonsillitis,
• allergic diathesis or any clinically significant allergic disease (i.e. asthma)
• any history of drug hypersensitivity (especially to β-glucan and related compounds)
• presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases
• clinically significant illness within 4 weeks before the start of the study
• intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the CRF.
• intake or administration of OTC medication (including herbal remedies) within 1 week prior to the start of the study
• concomitant intake or administration of any systemic or topical drugs (including herbal remedies)
• treatment with any investigational drug (i.e., drug not yet approved) in the last 2 months (60 days) before beginning of the trial
• medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months (60 days)

Sponsors & Collaborators

• Imuneks Farma ilac San. Tic. A.S.: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University Hakan Çetinsaya İKU

Kayseri, 38039, Turkey (Türkiye)

Location

Study Officials

• Ahmet İnal, Asst. Prof.

  Erciyes University Hakan Çetinsaya İKU Merkezi (Center for GCP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 21, 2016
• Study Start: February 27, 2017
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)