Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
5
ILD
To compare the level of oxygenation achieved during muscle training with conventional oxygen therapy systems (nasal cannula) and high-flow systems.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519541-30-00
- EudraCT number
- 2017-000895-27
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare the level of oxygenation achieved during muscle training with conventional oxygen therapy systems (nasal cannula) and high-flow systems.
Secondary objectives 4
- Compare the benefits achieved with the two oxygen therapy systems in terms of: Level of effort achieved during training
- Effort tolerance with the 6MWT after training
- Improvement in dyspnea
- Improvement in Health-Related Quality of Life
Conditions and MedDRA coding
ILD
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age > 30 years
- Diagnosis of Interstitial Lung Disease (ILD) according to national and international guidelines
- Signed informed consent form (Annex 1)
Exclusion criteria 8
- Participation in a Respiratory Rehabilitation (RR) program (including training) in the last 6 months
- Intolerance to the high-flow oxygen administration system; while no cases have been reported to date (Frat et al, New Engl J of Med 2015; 372: 2185-96; Stephan et al, JAMA 2015; 313: 2331-39)
- Respiratory diseases other than ILD
- Severe cardiac, neuromuscular, anemia, vascular diseases, or other serious comorbidities (primarily severe pulmonary hypertension per SEPAR Guidelines 2017)
- Osteoarticular diseases that hinder exercise performance
- Terminal illness (inability to perform exercises or treatment with opioids)
- Life expectancy < 6 months
- Cognitive disorders that prevent active participation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint will be the average SpO₂ achieved throughout the entire training period, comparing both groups.
Secondary endpoints 8
- Dyspnea during daily life activities (mMRC scale, dyspnea domain of the CRQ)
- Dyspnea during exertion before and after the 6-minute walk test (6MWT) (Borg scale)
- Exercise capacity measured by the 6MWT without oxygen support
- Health-Related Quality of Life (HRQoL) assessed using the KBILD and SF36 questionnaires
- Full pulmonary function test (spirometry, lung volumes, diffusion, and blood gases)
- Adverse effects of the program
- Adverse events
- Program adherence
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Conoxia 100% medicinal gas, cryogenic
PRD5085190 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 200 Other
- Max total dose
- 200 Other
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 20170216
- MA holder
- LINDE GAS BULGARIA EOOD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
CONOXIA, gas medicinal comprimido
PRD11384718 · Product
- Active substance
- Oxygen
- Substance synonyms
- OXYGENIUM
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 200 Other
- Max total dose
- 200 Other
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 67166
- MA holder
- LINDE GAS ESPANA S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 60 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital De La Santa Creu I Sant Pau
Neumología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Neumología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Neumología, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Del Mar
Neumología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
University Hospital Virgen Del Rocio S.L.
Neumología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-11-27 | 2024-11-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol for publication | 7 |
| Recruitment arrangements (for publication) | L1_SIS and ICF for publication | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for publication | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Conoxia_comp | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Conoxia_comp | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-25 | Spain | Acceptable 2024-11-27
|
2024-11-27 |