The Effect of Pseudoephedrine on Rhinitis and Sleep
Mots clés
Abstrait
La description
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.
Rendez-vous
| Dernière vérification: | 08/31/2017 |
| Première soumission: | 06/23/2008 |
| Inscription estimée soumise: | 06/23/2008 |
| Première publication: | 06/24/2008 |
| Dernière mise à jour soumise: | 09/19/2017 |
| Dernière mise à jour publiée: | 10/17/2017 |
| Date des premiers résultats soumis: | 09/19/2017 |
| Date de la première soumission des résultats du CQ: | 09/19/2017 |
| Date des premiers résultats publiés: | 10/17/2017 |
| Date de début réelle de l'étude: | 05/31/2007 |
| Date d'achèvement primaire estimée: | 08/31/2009 |
| Date estimée d'achèvement de l'étude: | 08/31/2009 |
Condition ou maladie
Intervention / traitement
Drug: Pseudoephedrine
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Placebo Comparator: Placebo Placebo | |
| Active Comparator: Pseudoephedrine Pseudoephedrine is a 240 mg PO per day |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: 1. Age 18 to 65. 2. History of allergic rhinitis. 3. The ability to be placed on placebo without significant compromise in the quality of life. 4. General good health. 5. Ability to comply with the protocol and sign an informed consent. 6. Have daytime sleepiness by history. 7. Have poor sleep by history. 8. Have fatigue by history. 9. Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms. Exclusion Criteria: 1. Age fewer than 18 or over 65 years. 2. A history of sleep apnea. 3. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma. 4. Non-allergic rhinitis. 5. Hypertension 6. Diabetes Mellitus 7. Inability to tolerate pseudoephedrine 8. Significant other diseases as determined by the investigator. 9. Use of a research medication within 30 days. 10. Use of a nasal steroid or topical antihistamine or decongestant within 30 days. 11. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers. 12. Excessive use of alcohol or drug abuse. 13. Inability to stop medication use during run-in period. 14. Use of an oral antihistamine within 1 week of enrollment. 15. Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past |
Résultat
Mesures des résultats primaires
1. Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo [3 years]
Mesures des résultats secondaires
1. Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo [3 years]
