Benefits of inhalation of 7% hypertonic saline solution prior to ELTGOL physiotherapy, in patients with bronchiectasis. A randomized controlled trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitari De Girona Doctor Josep Trueta

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

20 Jun 2024 → ongoing

Decision date (initial)

2024-11-05

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

FIS Exp ICI23/00073

External identifiers

EU CT number

2024-511677-29-01

EudraCT number

2020-001026-62

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Efficacy

To evaluate the effect of the combination of once-daily 7% hypertonic saline and twice-daily ELTGOL technique in mucus clearance in patients with bronchiectasis compared both to once-daily isotonic saline and twice-daily ELTGOL technique and to twice-daily ELTGOL technique on its own

Secondary objectives 4

1. To evaluate the effects of the three treatment regimes on the impact of cough, exacerbations, mucus properties, quality of life, sputum cultures and pulmonary function in these patients. - To assess possible side effects - To assess adherence to the different regimes - To assess whether the effects are sustained one month after the treatment is ended
2. To assess possible side effects of HS
3. To assess adherence to the different regimes
4. To assess whether the effects are sustained one month after the treatment is ended

Conditions and MedDRA coding

BRONCHIECTASIA

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Men and woman ≥ 18 years old
2. Bronchiectasis confirmed by high resolution computed tomography
3. no exacerbations in the previous month
4. chronic purulent sputum ( ≥10ml daily expectoration)
5. at least one exacerbation in the previous year
6. FEV1 ≥30% after bronchodilation
7. sign the informed consent

Exclusion criteria 8

1. patients > 85 years old
2. asthma, allergic bronchopulmonary aspergillosis or cystic fibrosis
3. current smokers or a smoking history of ≥20 pack/year
4. following mucoactive treatment in the previous month
5. contraindications to perform ELTGOL, spirometry or to attend visits
6. pulmonary rehabilitation in the previous 6 months
7. change of treatment the previous month
8. uncontrolled hypertension

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. change in the sputum weight in grams during intervention from baseline to V7

Secondary endpoints 9

1. Change from baseline in the 24h sputum volume in millilitres and sputum weight (defined as the sputum volume during the intervention and 24 hours later) over the 12-month treatment period.
2. Change in cough assessed with the Leicester Cough Questionnaire26 from V2 over the 12-month treatment period
3. Number of exacerbations and the time to the first exacerbation over the 12-month treatment period
4. Change in sputum purulence assessed by the sputum colour chart, mucus properties, and microbiology from V2 to V7.
5. Change in quality of life (assessed with Bronchiectasis health questionnaire and Saint George Respiratory questionnaire) from V2 over the 12-month treatment period
6. Change from V2 in post-bronchodilator FEV1 over the 12-month treatment period in ml
7. Treatment adherence assessed through vial counting, Morisky-Green test, the diary card.
8. Adverse events assessed by symptoms reported, vital sign measurement (including blood pressure and arterial oxygen saturation), physical examination, Borg scale at the end of interventions at V2, V3, V5, V7, and pulmonary function tests at V2.
9. Change from V7 to V8 in the 24h sputum volume, colour and weight, quality of life and FEV1

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitari De Girona Doctor Josep Trueta

Sponsor organisation

Hospital Universitari De Girona Doctor Josep Trueta

Address

Avinguda De Franca S/n

City

Girona

Postcode

17007

Country

Spain

Scientific contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Principal Investigator

Public contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Principal Investigator

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications