NCT00961155 is a Phase 2 clinical trial of cyklezonid in Asthma, sponsored by Medical University of Lodz.

Who is sponsoring NCT00961155?

NCT00961155 is sponsored by Medical University of Lodz.

What drugs are being tested in NCT00961155?

Interventions in NCT00961155: cyklezonid, montelukast sodium, placebo, formoterol 12 mcg twice daily.

Is NCT00961155 still recruiting?

NCT00961155 is currently status unknown. Last updated 9 December 2013.

Last reviewed 2013-12-09 · How we verify

NCT00961155

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma

Status unknown Phase 2 Last updated 9 December 2013

What this trial tests

Phase 2 trial testing cyklezonid in Asthma in 200 participants. Status unknown.

Timeline

1 August 2009

Primary endpoint
1 December 2013

1 June 2014

Quick facts

Lead sponsor	Medical University of Lodz
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	200
Start date	1 August 2009
Primary completion	1 December 2013
Estimated completion	1 June 2014
Sites	1 location across Poland

Drugs / interventions tested

cyklezonid — full drug profile →
montelukast sodium — full drug profile →
placebo
formoterol 12 mcg twice daily — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Medical University of Lodz

Who can join

Adults 6 to 17, any sex, with Asthma. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.
Time frame: visit 1-6

Sponsor's own description

Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

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NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Medical University of Lodz trials

Trials by the same sponsor.

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NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · recruiting
NCT06850597 — Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's D · Phase 2 · recruiting
NCT06917300 — Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery · NA · recruiting
NCT06391216 — The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00961155 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of Lodz
Last refreshed: 9 December 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00961155.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing