NCT00504946 is a Phase 3 clinical trial of prednisone, lactose in Asthma, sponsored by Medical University of Lodz.

Who is sponsoring NCT00504946?

NCT00504946 is sponsored by Medical University of Lodz.

What drugs are being tested in NCT00504946?

Interventions in NCT00504946: prednisone, lactose, prednisone, colecalciferol, lactose, lactose, montelukast sodium, lactose.

Is NCT00504946 still recruiting?

NCT00504946 is currently completed. Last updated 8 April 2008.

Last reviewed 2008-04-08 · How we verify

NCT00504946

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

The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study

Completed Phase 3 Last updated 8 April 2008

What this trial tests

Phase 3 trial testing prednisone, lactose in Asthma in 85 participants. Completed in 1 March 2007.

Timeline

1 September 2005

Primary endpoint
1 March 2007

1 March 2007

Quick facts

Lead sponsor	Medical University of Lodz
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	85
Start date	1 September 2005
Primary completion	1 March 2007
Estimated completion	1 March 2007
Sites	1 location across Poland

Drugs / interventions tested

prednisone, lactose — full drug profile →
prednisone, colecalciferol, lactose — full drug profile →
lactose (Lactose) — full drug profile →
montelukast sodium — full drug profile →
lactose (Lactose) — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Medical University of Lodz

Who can join

Adults 6 to 18, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

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

Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)

Sponsor's own description

There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.
Chauhan BF, Ducharme FM. · · 2012 · cited 80× · PMID 22592685 · DOI 10.1002/14651858.cd002314.pub3

Verify or expand the search:

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Other Medical University of Lodz trials

Trials by the same sponsor.

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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 NCT00504946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 8 April 2008

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/NCT00504946.

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