Impact of Topical Sinonasal Budesonide Irrigation on Hypothalamic-Pituitary-Adrenal Axis Function
|ClinicalTrials.gov Identifier: NCT01373528|
Recruitment Status : Terminated
First Posted : June 15, 2011
Last Update Posted : May 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis||Drug: Budesonide irrigation||Not Applicable|
CRS is an inflammatory disease of the paranasal sinuses that is difficult to treat. Current treatment strategies rely upon medical treatment with the long-term daily use of a topical corticosteroid as its foundation. Once medical therapy becomes ineffective at controlling CRS and its resultant symptoms, surgical treatment is offered. Following surgery, patients must again continue with medical treatment to control the inflammation present in CRS. Previously, topical steroids could be applied using only a commercially prepared applicator that is effective at treating no more than the front of the nose and parts of the paranasal sinuses. However, relatively new nasal saline irrigation devices have made it possible to treat all of the paranasal sinuses. Corticosteroid medication can be added directly to the saline irrigation. In an operated patient the sinus openings have been greatly enlarged which then allows the irrigation to more effectively reach all of the paranasal sinuses. Therefore, irrigation with a corticosteroid solution allows for better delivery of the corticosteroid medication to treat the mucosal inflammation that is widely present. More effective treatment of the paranasal sinus inflammation thereby leads to improved control of inflammation and to the alleviation of patient symptoms such as chronic facial and dental pain, headache, obstructed nasal breathing, loss of smell and discharge from the nose. As of yet, with this method of treatment it has not been determined whether there is significant systemic absorption and a resultant suppression of the HPA axis.
The investigators hypothesize that:
- a single 0.5 mg dose of budesonide will result in acute but recoverable suppression of pituitary adrenocorticotrophic hormone (ACTH) secretion with a resultant transient decrease in adrenal cortisol production; and that
- the long term use of budesonide, 0.5 mg twice daily (BID), will result in a gradual and cumulative suppression of the HPA axis to the extent that significant hypocortisolism will be present when budesonide irrigation is discontinued necessitating replacement glucocorticoid therapy.
Specific Aim of Project This study will determine if there is acute recoverable and long-term suppression of the HPA axis when budesonide irrigations are used in patients with CRS following endoscopic sinus surgery. This important information is currently not available in the literature.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Topical Sinonasal Budesonide Irrigation on Hypothalamic-Pituitary-Adrenal (HPA) Axis Function|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Drug: Budesonide irrigation
A budesonide (1 mg) in saline (240 mL) irrigation solution is applied to the sinonasal cavities twice daily. 120 mL of the solution is applied via irrigation in the AM, and 120 mL again in the PM.
- Serum cortisol levels before and after treatment [ Time Frame: 12 months ]
- ACTH stimulation test cortisol level [ Time Frame: 12 months ]
- Urinary Free Cortisol Levels [ Time Frame: Every 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373528
|Ottawa Hospital Riverside Campus|
|Ottawa, Ontario, Canada, K1H 4E9|
|Principal Investigator:||Kilty Shaun, MD||OHRI|