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Clinical Trials/EUCTR2004-000091-14-SE
EUCTR2004-000091-14-SE
Active, not recruiting
Not Applicable

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 52 Weeks in Adult and Adolescent Subjects with Perennial Allergic Rhinitis

GlaxoSmithKline AB0 sites736 target enrollmentJune 30, 2004
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
GlaxoSmithKline AB
Enrollment
736
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 30, 2004
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • •1\. Subject has provided an appropriately signed and dated informed consent and one has been obtained from the subject’s parent or guardian if the child is under 18 years of age.
  • •2\. Subjects must be \>\=12 years of age at Visit 1, either gender, any ethnic group.
  • •3\. Subject is treatable on an outpatient basis.
  • •4\. Gender: Male or female
  • •To be eligible for entry into the study, females of child\-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following:
  • •\- Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
  • •\- Implants of levonorgestrel
  • •\- Injectable progestogen
  • •\- Oral contraceptive (either combined or progestin only)

Exclusion Criteria

  • •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • •1\. Significant concomitant medical conditions, defined as:
  • •a) A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., active tuberculosis, psychological disorders). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
  • •b) a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug
  • •c) recent (in the last 6 months) nasal septal or facial cosmetic surgery
  • •d) asthma, with the exception of mild intermittent asthma \[NAEPP, 2002] and the \[GINA, 2003]. For Canada, see Canadian Asthma Consensus Report, \[Boulet, 1999] for guidelines for very mild intermittent asthma). NOTE: Subjects will be allowed to use short\-acting inhaled beta2 agonists ONLY on an as needed basis.
  • •e) rhinitis medicamentosa
  • •f) bacterial or viral infection (e.g., common cold) of the upper respiratory tract within two weeks of Visit 1 or during the screening period
  • •g) documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
  • •h) current or history of glaucoma and/or cataracts or ocular herpes simplex

Outcomes

Primary Outcomes

Not specified

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