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PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled Tiotropium (PRETIO)

15. September 2026 aktualisiert von: Jana Tuková, General University Hospital, Prague

A Prospective, Randomized, Controlled, Crossover Phase IV Study to Evaluate the Efficacy and Safety of Inhaled Tiotropium in Preterm Infants With Bronchial Obstruction Compared to Standard Treatment

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This clinical trial is designed as an investigator-initiated, academic, phase IV, randomized, open-label, 2x2 crossover study to evaluate the response to inhaled tiotropium bromide in children and adolescents born prematurely who suffer from chronic bronchial obstruction.

The study consists of two different sequences:

  • Sequence A (Treatment first): Participants receive inhaled tiotropium (5 µg once daily via Spiriva Respimat) for 3 months, followed by a 4-week washout period, and subsequently undergo a 3-month control observation period under standard treatment.
  • Sequence B (Control first): Participants start with a 3-month control observation period under standard treatment, followed immediately (without a washout period) by a 3-month treatment period with daily inhaled tiotropium.

Clinical and spirometric assessments (including Forced Expiratory Volume in 1 second in liters - FEV₁, Forced Vital Capacity in liters - FVC, Peak Expiratory Flow in liters per second - PEF, Forced Expiratory Flow between 25% and 75% of FVC in liters per second - FEF₂₅-₇₅ parameters) will be performed at baseline, at the crossover point (end of the first period), and at the end of the study (end of the second period). Participants or their parents will maintain daily diaries to log respiratory symptoms, rescue medication - short-acting beta₂-agonist (SABA) use, and potential acute exacerbations throughout the trial.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Tschechien
      • Prague, Tschechien, 128 08
        • General University Hospital in Prague, Department of Paediatrics and Inherited Metabolic Disorders (KPDPM)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.
  • Positive bronchodilatation test, defined as an increase in FEV₁ or FVC of more than 10% of the corresponding GLI-predicted value following administration of ipratropium bromide. Bronchodilator responsiveness will be calculated separately for FEV₁ and FVC as:

[(post-bronchodilator value - pre-bronchodilator value) / predicted value] × 100.

FEV₁ and FVC will be measured in litres (L) after ipratropium administration.

  • Acceptable spirometry performance in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 standards.
  • No long-term inhalation therapy (such as a long-acting beta₂-agonist (LABA) or a combination of an inhaled corticosteroid and a long-acting beta₂-agonist (ICS/LABA)) within the last month prior to study enrollment.

Exclusion Criteria:

  • 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.
  • Pregnancy (mandatory urine screening required for all female participants aged 13 years and older).
  • Insufficient cooperation or inability to properly perform spirometry maneuvers.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sequence A: Tiotropium first
Participants in this sequence receive inhaled tiotropium bromide (5 µg once daily via Spiriva Respimat) for 3 months, followed by a 4-week washout period, and then undergo a 3-month control observation period with standard treatment.
Arzneimittel: tiotropium bromide (Spiriva Respimat)
Inhaled 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.
Experimental: Sequence B: Control first
Participants in this sequence begin with a 3-month control observation period under standard treatment (no long-term anticholinergic therapy), immediately followed by a 3-month treatment period with daily inhaled tiotropium (5 µg once daily).
Arzneimittel: tiotropium bromide (Spiriva Respimat)
Inhaled 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Absolute change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) expressed in liters (L)
Zeitfenster: At the end of the 3-month treatment period and at the end of the 3-month control period (specifically at Week 12 and Week 28 for Sequence A, or at Week 12 and Week 24 for Sequence B)

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).
At the end of the 3-month treatment period and at the end of the 3-month control period (specifically at Week 12 and Week 28 for Sequence A, or at Week 12 and Week 24 for Sequence B)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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])
Zeitfenster: At the end of the 3-month treatment period and at the end of the 3-month control period (specifically at Week 12 and Week 28 for Sequence A, or at Week 12 and Week 24 for Sequence B)
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.
At the end of the 3-month treatment period and at the end of the 3-month control period (specifically at Week 12 and Week 28 for Sequence A, or at Week 12 and Week 24 for Sequence B)
Frequency of Acute Respiratory Exacerbations and Rescue Medication Use
Zeitfenster: Continuously throughout both 3-month periods (treatment and control) and the 4-week washout phase, evaluated over a total span of up to 7 months per participant.
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.
Continuously throughout both 3-month periods (treatment and control) and the 4-week washout phase, evaluated over a total span of up to 7 months per participant.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

General University Hospital, Prague

Ermittler

  • Hauptermittler: Jana Tuková, MUDr., Ph.D., General University Hospital, Prague

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Mai 2029

Studienabschluss (Geschätzt)

1. August 2029

Studienanmeldedaten

Zuerst eingereicht

20. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. September 2026

Zuerst gepostet (Tatsächlich)

18. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PRETIO-2026
  • 2026-525773-39-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared to protect patient privacy, as this study evaluates a vulnerable pediatric population and is subject to strict GDPR and institutional data protection regulations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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