The purpose of this clinical trial is to evaluate the efficacy and safety of inhaled tiotropium bromide (Spiriva Respimat) in preterm-born children and adolescents suffering from chronic bronchial obstruction.
Preterm infants often experience persistent narrowing of the airways, which leads to shortness of breath, chronic respiratory symptoms, and reduced exercise tolerance.
Tiotropium is a long-acting muscarinic antagonist (LAMA) that helps dilate the airways and facilitate breathing. While this medication is already approved for pediatric patients aged 6 years and older with severe asthma, its efficacy and safety have not yet been validated in the specific population of preterm infants with bronchial obstruction. This study aims to fill this clinical knowledge gap.
This is a non-commercial, monocentric, prospective, randomized, open-label, phase IV study utilizing a 2x2 crossover design. The trial will enroll 50 participants aged 6 to 18 years. Each participant will undergo two distinct 3-month phases: a treatment period with daily inhaled tiotropium (5 µg once daily) and a control observation period without long-term anticholinergic therapy. The sequence of these periods will be randomly assigned to each participant. The primary objective is to demonstrate lung function improvement by evaluating the change in forced expiratory volume in 1 second (FEV1) expressed in liters and Forced Vital Capacity (FVC) expressed in liters between the treatment and control periods. No blood samples or invasive procedures are required for this study.
Age between 6 and 18 years.
History of preterm birth (defined as delivery at < 37 gestational weeks).
Spirometrically proven bronchial obstruction, defined as a z-score of FEV1 and/or >= 2 other parameters - Forced Vital Capacity (FVC; liters [L]), Peak Expiratory Flow (PEF; liters per second [L/s]), and Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75; liters per second [L/s]).) below -1.65 SD.
Acceptable spirometry performance in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 standards.
Other chronic respiratory diseases (e.g., asthma, cystic fibrosis).
Anatomical abnormalities of the respiratory tract or presence of glaucoma.
Congenital malformations of the uropoetic tract or cardiac arrhythmias/congenital heart defects.
Concomitant use of anticholinergic medications for enuresis nocturna.
Crossover
tiotropium bromide (Spiriva Respimat)
DrugInhaled tiotropium bromide administered via Spiriva Respimat inhaler. Dose: 5 µg (2 actuations of 2.5 µg) once daily for a total duration of 12 weeks.
Absolute change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) expressed in liters (L)
The outcome will be the within-participant difference in forced expiratory volume in 1 second (FEV₁), expressed in litres (L) and Forced Vital Capacity in liters - FVC, between the end of the 3-month tiotropium treatment period and the end of the 3-month control observation period. FEV₁ and FVC will also be expressed as a z-score and percentage of the predicted value calculated using the applicable Global Lung Function Initiative (GLI) reference equations. The treatment effect will be calculated as: FEV₁ after the tiotropium treatment period (L) - FEV₁ after the control observation period (L).
Change from Baseline in Secondary Spirometric Parameters (FVC expressed in liters [L], PEF in liters per second [L/s], and MEF25-75 in liters per second [L/s])
The absolute changes in Forced Vital Capacity (FVC, expressed in liters \[L\]), Peak Expiratory Flow (PEF, expressed in liters per second \[L/s\],), and Forced Expiratory Flow at 25%, 50%, and 75% of FVC (FEF25-75, expressed in liters per second \[L/s\],) evaluated between the end of the 3-month tiotropium treatment period and the end of the 3-month control observation period.
Frequency of Acute Respiratory Exacerbations and Rescue Medication Use
The total number of acute respiratory exacerbations and the frequency of rescue medication (Short-acting Beta-2 Agonist - SABA) usage tracked via daily patient/parent diaries during the 3-month tiotropium treatment period compared to the 3-month control observation period.
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