Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Condition: Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Recurrence
Intervention: celebrex (celecoxib); placebo
Intervention description: Adults: 400 mg celebrex (celecoxib) daily Pediatrics: 100 mg celebrex (celecoxib) daily for weight between 12-25 kg or 200 mg Celebrex (celecoxib) daily for weight >25 kg; similar appearing capsules containing inert ingredients
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: HPV; RRP

Summary:

      This is a randomized double blind controlled study to determine if celebrex (celecoxib), a
      selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric
      patients with recurrent respiratory papillomatosis. All patients will be evaluated for
      disease severity at enrollment and at 3 month intervals for 30 months. After randomization,
      patients in the early treatment arm will begin celecoxib 6 months after enrollment. The
      delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will
      receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they
      will receive a placebo capsule with the same appearance. Follow-up visits will occur at three
      month intervals for the duration of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe disease, defined as:

        Patients who have rapid regrowth of papillomas, requiring endoscopic removal at least 3
        times within the past 12 months AND A papilloma growth rate from 0.03 to 0.06 (moderate) or
        >0.06 (severe) at time of initial direct endoscopy OR Having tracheal and/or bronchial or
        pulmonary papillomatosis (severe)

          -  Age > 2 years

          -  Gender- no restriction

          -  Race- no restriction

        Exclusion Criteria:

          -  Fewer than 3 surgical procedures in previous year, without tracheal disease

          -  Age < 2 years

          -  Pregnancy, trying to become pregnant, breastfeeding or not willing to comply with
             birth control methods if sexually active female

          -  Serum creatinine > 1.5 X normal

          -  History of documented peptic ulcer disease or gastritis persisting despite treatment

          -  Abnormal liver function tests, as total bilirubin >1.5 X normal and SGOT > 3 X normal

          -  Allergy to NSAIDs, sulfa containing drugs or symptoms of Stevens-Johnson Syndrome

          -  Patients with connective tissue diseases such as SLE, Raynaud's or Systemic Sclerosis

          -  Patients with known diabetes

          -  Patients on warfarin, or on loop or thiazide diuretics

          -  Patients with a history of cardiovascular disease, myocardial infarct or stroke

          -  Patients with congestive heart failure

          -  Patients regularly taking > 81 mg of aspirin/day

          -  Patients with uncontrolled hypertension

          -  Patients with RRP associated malignancy currently receiving chemotherapy and/or
             radiation