Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)

Bionorica

Status and phase: Completed; Phase 2

Conditions: Current Smokers

Treatments: Drug: administration of Sinupret; Drug: administration of Bronchipret Placebo; Drug: administration of Sinupret Placebo; Drug: administration of Bronchipret

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928901

Saccharin test

Details and patient eligibility

About

Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance

Enrollment: 56 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Volunteers who have given their signed declaration of consent and have signed the data protection declaration
2. Male or female volunteers 25 - 40 years
3. Current smokers (5-20 cigarettes per day since 5 years at least)
4. Ability to taste sweetness of saccharin
5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve

Exclusion criteria

1. Ciliary dyskinesia
2. Cystic fibrosis
3. COPD/emphysema
4. Asthma
5. Chronic rhinosinusitis
6. Acute respiratory tract infection within the last 6 weeks prior to enrolment
7. Septal or sinus surgery
8. Symptomatic allergic rhinitis
9. Known allergic rhinitis
10. Treatment with not-permitted previous or concomitant therapy
11. History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month
12. Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

56 participants in 4 patient groups, including a placebo group

administration of Bronchipret

Experimental group

Description:

7 days of administration of Bronchipret, 2 FCT t.i.d

Treatment:

Drug: administration of Bronchipret Placebo

Drug: administration of Bronchipret

administration of Sinupret

Experimental group

Description:

7 days of administration of Sinupret, 2 CT t.i.d

Treatment:

Drug: administration of Sinupret Placebo

Drug: administration of Sinupret

administration of Bronchipret Placebo

Placebo Comparator group

Description:

7 days of administration of Bronchipret Placebo, 2 FCT t.i.d

Treatment:

Drug: administration of Bronchipret Placebo

Drug: administration of Bronchipret

administration of Sinupret Placebo

Placebo Comparator group

Description:

7 days of administration of Sinupret Placebo, 2 CT t.i.d

Treatment:

Drug: administration of Sinupret Placebo

Drug: administration of Sinupret