Who is sponsoring NCT01582555?

NCT01582555 is sponsored by Tel-Aviv Sourasky Medical Center.

What drugs are being tested in NCT01582555?

Interventions in NCT01582555: saline nasal irrigation alone, dissolved N-Acetylcystine.

What condition does NCT01582555 study?

NCT01582555 studies Surgical Procedure, Unspecified.

Is NCT01582555 still recruiting?

NCT01582555 is currently status unknown. Last updated 19 April 2012.

Last reviewed 2012-04-19 · How we verify

NCT01582555

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

Postoperative Nasal Irrigation Using Mucolytic Agents in Patients Undergoing Endoscopic Sinus Surgery

Status unknown NA Last updated 19 April 2012

What this trial tests

NA trial testing saline nasal irrigation alone in Surgical Procedure, Unspecified in 44 participants. Status unknown.

Timeline

1 June 2012

Primary endpoint
1 June 2013

1 December 2013

Quick facts

Lead sponsor	Tel-Aviv Sourasky Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 June 2012
Primary completion	1 June 2013
Estimated completion	1 December 2013
Sites	1 location across Israel

Drugs / interventions tested

saline nasal irrigation alone — full drug profile →
dissolved N-Acetylcystine — full drug profile →

Conditions studied

Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

18 and older, any sex, with Surgical Procedure, Unspecified. 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.

change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores
Time frame: 1 y
The primary outcome measure is change in QOL based on the Sino-Nasal Outcome Test-22 (SNOT-22) scores.(5) SNOT-22 scores were chosen as the primary outcome due to the importance of studying patient QOL outcomes as opposed to imaging or endoscopy scores that often do not correlate with patients' subjective perceptions of disease severity.

Sponsor's own description

Nasal irrigation techniques have been used for many years and been shown to improve symptoms of rhinosinusitis. Although there is a wealth of literature available, establishing treatment protocols can be difficult because of the great variability in recommended composition (seawater or hypertonic or isotonic saline with or without additives) and irrigation technique (variations in pressure and volume). Nasal irrigation is also used in many centers as part of postoperative treatment protocols and in particular has been recommended following endoscopic sinus surgery (ESS). Nasal crusting and thick nasal discharge have a negative impact on these patients quality of life (QOL). At the time of our study, there are no studies comparing irrigation with mucolysis with saline irrigation following ESS. The investigators aimed to assess whether mucolysis is effective at improving patients QOL and reducing postoperative signs as assessed endoscopically.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Tel-Aviv Sourasky Medical Center 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 NCT01582555 (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 Tel-Aviv Sourasky Medical Center
Last refreshed: 19 April 2012

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/NCT01582555.

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