Overview
Sponsor-declared trial summary
Chronic Obstructive Plumonary Disease (COPD)
To assess the effect of 1 dose with oxymetazoline nasal spray(Otrivin®) on the physical capacity of patients suffering from Chronic Obstructive Pulmonary Disease (COPD)
Key facts
- Sponsor
- Sorlandet Sykehus HF
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sørlandet Hospital
External identifiers
- EU CT number
- 2024-520177-12-00
- EudraCT number
- 2020-005013-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess the effect of 1 dose with oxymetazoline nasal spray(Otrivin®) on the physical capacity of patients suffering from Chronic Obstructive Pulmonary Disease (COPD)
Conditions and MedDRA coding
Chronic Obstructive Plumonary Disease (COPD)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants who comply with the standard diagnostic criteria for Chronic Obstructive Pulmonary Disease, COPD, as defined in the GOLD standard (Shireen M. 2028)
Exclusion criteria 3
- Active malignant disorders
- Other obstructive pulmonary disorders.
- Pragnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- walking distance
Secondary endpoints 1
- Borg scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Nasolin 1 mg/ml nenäsumute, liuos
PRD507961 · Product
- Active substance
- Xylometazoline Hydrochloride
- Pharmaceutical form
- NASAL SPRAY
- Route of administration
- NASAL SPRAY
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R01AA07 — XYLOMETAZOLINE
- Marketing authorisation
- 22617
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sorlandet Sykehus HF
- Sponsor organisation
- Sorlandet Sykehus HF
- Address
- Egsveien 100
- City
- Kristiansand S
- Postcode
- 4615
- Country
- Norway
Scientific contact point
- Organisation
- Sorlandet Sykehus HF
- Contact name
- Sverre Steinsvaag
Public contact point
- Organisation
- Sorlandet Sykehus HF
- Contact name
- Sverre Steinsvaag
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520177-12-00 | 2 |
| Protocol (for publication) | D4_Patient facing documents_BORG skala | 1 |
| Protocol (for publication) | D4_Patient facing documents_VAS-skjema | 1 |
| Recruitment arrangements (for publication) | Placeholder_2024-520177-12-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Otrivin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-19 | Norway | Acceptable 2025-01-24
|
2025-01-24 |