Decongestant effect on the respiratory tract of subjects suffering from chronic obstructive pulmonary disease of a sterile class IIb medical device called UNCADEP® AEROSOL
| ISRCTN | ISRCTN58370332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58370332 |
| Secondary identifying numbers | 1/23 ASL NA 1 |
- Submission date
- 25/07/2024
- Registration date
- 13/08/2024
- Last edited
- 13/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
UNCADEP® AEROSOL was marketed in Italy from 2017 until early 2023. Following the expiration of its CE certificate under Directive 93/42/EEC (MDD), it needs to be reintroduced to the market in compliance with the new Regulation (EU) 2017/745 (MDR), with some modifications to its properties: vial volume (from 2 ml to 5 ml); concentration of N-acetylcysteine (from 15% to 6%) and hyaluronic acid (from 0.1% to 0.05%); and molecular weight of hyaluronic acid (from 850-1150 kDa to 1100-1600 kDa).
As a result, this study was designed to reconfirm the effectiveness and safety of the reformulated device in the treatment of catarrhal conditions (inflammation) of the respiratory tract. Ultimately, the study aims to evaluate an inhalation preparation (hypertonic saline solution with N-acetylcysteine and hyaluronic acid) that offers a unique combination of mucolytic (breaking up mucus) and protective activities in the respiratory tract, which may be particularly beneficial for patients with COPD.
Who can participate?
Patients aged 40 years and over with COPD
Who does the study involve?
Patients are randomly allocated into two groups:
UNCADEP AEROSOL treatment group: COPD therapy integrated with UNCADEP® AEROSOL twice daily (morning and evening) for 10 days.
Control group: COPD therapy integrated with isotonic saline solution aerosol twice daily (morning and evening) for 10 days.
The patients are monitored 2 weeks before treatment, immediately before and after treatment, and 2 weeks after treatment.
What are the possible benefits and risks of participating?
The participants should benefit from the use of this medical device. It can help clear inflamed airways, improve expectoration, and thus promote respiratory function. There are no particular risks associated with using this device; tolerable side effects are possible: bronchospasm (airway contractions), bronchial obstruction, rhinorrhea (runny nose), nausea, vomiting, stomatitis (inflamed mouth), skin rash and itching.
Where is the study run from?
Presidio Ospedaliero dei Pellegrini, Ambulatorio di Pneumologia (Italy)
When is the study starting and how long is it expected to run for?
January 2024 to September 2024
Who is funding the study?
Erbozeta S.p.A. (Italy)
Who is the main contact?
Dr Lucia Gallinaro, accettazioneobi.pellegrini@aslnapoli1centro.it
Contact information
Principal Investigator
Presidio Ospedaliero dei Pellegrini
Ambulatorio di Pneumologia
Via Portamedina alla Pignasecca 41
Napoli
80134
Italy
| Phone | +39 (0)81 254 34 01 |
|---|---|
| accettazioneobi.pellegrini@aslnapoli1centro.it |
Public, Scientific
Via Domenico Fontana
Napoli
80131
Italy
 ORCID ID |
0000-0002-0251-9936 |
|---|---|
| Phone | +39 (0)3398774688 |
| giancarlo.tenore@unina.it |
Study information
| Study design | Pre-marketing controlled parallel-group randomized open single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Decongestant effect on the respiratory tract of subjects suffering from chronic obstructive pulmonary disease of a sterile class IIb medical device called UNCADEP® AEROSOL |
| Study acronym | DECUNCA |
| Study objectives | The clinical investigation is aimed to systematically evaluate the clinical validity of preparation for inhalation use (hypertonic saline solution with N-acetylcysteine and hyaluronic acid) having a peculiar combination of mucolytic and protective activity in the airways, which can be particularly beneficial for patients with chronic obstructive pulmonary disease (COPD). This preparation is supposed to improve the respiratory function and quality of life of patients with COPD, without significant side effects. |
| Ethics approval(s) |
Approved 05/03/2024, Comitato etico territoriale Campania 1 (Fondazione Giovanni Pascale, via Mariano Semmola 52, Napoli, 80131, Italy; +39 (0)81 17770131; comitatoetico@istitutotumori.na.it), ref: Protocollo: 1/23 ASL NA 1 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | The randomization starts after 14 days of run-in/enrollment phase. The patients are randomly divided into two groups of 30 each by drawing envelopes containing randomisation numbers. The random number list was generated by an investigator with no clinical involvement in the trial. UNCADEP® AEROSOL Treatment group (n = 30): COPD therapy integrated with UNCADEP® AEROSOL, 1 vial of 5 ml per nebulization session, two times a day (morning and evening), for 10 days. Control (n = 30): COPD therapy integrated with isotonic saline solution aerosol, one vial of 5 ml per nebulization session, two times a day (morning and evening), for 10 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Device |
| Primary outcome measure | 1. Objective respiratory function (FEV1) measured using spirometry at baseline and after 10 days of treatment 2. Serious adverse events in probable or certain correlation with the correct use of the device, recorded during the treatment period |
| Secondary outcome measures | 1. Perceived respiratory function measured using mMRC score (5-point scale) by a questionnaire at baseline and after 10 days of treatment 2. Quality of life measured using CAT score (40-point scale) by a questionnaire at baseline and after 10 days of treatment |
| Overall study start date | 15/01/2024 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Caucasian ethnicity 2. Ability to understand the Italian language 3. Age ≥40 years 4. COPD diagnosed, also by spirometry, for at least 12 months 5. COPD treated pharmacologically and stable for at least 4 weeks 6. COPD associated with expectoration difficulties |
| Key exclusion criteria | 1. Pregnancy and breastfeeding 2. Other kinds of chronic bronchopulmonary diseases, hemoptysis; current or past gastrointestinal ulcers 3. Renal or hepatic insufficiency 4. HIV infection 5. Neoplasms 6. Hypersensitivity to one or more components of the study products 7. Ongoing therapy with other mucoactive agents, antitussives, anticholinergics, or nitroglycerin |
| Date of first enrolment | 19/06/2024 |
| Date of final enrolment | 06/09/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Naples
80134
Italy
Sponsor information
Other
Strada delle Seriole 41/43
Chiesanuova
47894
Italy
| Phone | +39 (0)549 907000 |
|---|---|
| regolatorio@erbozeta.com | |
| Website | https://www.erbozeta.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Giancarlo Tenore (giancarlo.tenore@unina.it). The data available are files (Word format) containing migraine diaries that were filled out by patients during the clinical trial. |
Editorial Notes
01/08/2024: Study's existence confirmed by Comitato etico territoriale Campania 1.
