Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

Browse trials for

• Rhinitis 1,105
• Rhinitis, Allergic 1,030
• Rhinitis, Allergic, Perennial 180

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 107 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Study arms

• Placebo comparator
  Placebo

  Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.

  Drug: Placebo Nasal Aerosol · Drug: Placebo Prednisone Capsules

• Experimental
  BDP HFA 320 µg/day

  Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.

  Drug: Placebo Prednisone Capsules · Drug: Beclomethasone dipropionate

• Active comparator
  Prednisone

  Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.

  Drug: Placebo Nasal Aerosol · Drug: Prednisone capsules

Interventions

• DrugPlacebo Nasal Aerosol

  Placebo nasal aerosol administered daily for 42 days of treatment

• DrugPrednisone capsules

  Prednisone 10 mg capsule taken each day on the last 7 days of treatment

• DrugPlacebo Prednisone Capsules

  Placebo prednisone capsule taken each day on the last 7 days of treatment

• DrugBeclomethasone dipropionate

  Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

  Also known as: QNASL(TM)

Primary outcomes

1. The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment

   Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.

   Time frame: Day 0 (Baseline), Day 42

Baseline characteristics

Publications

• Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188
• Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
• Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005. PubMed 23062389 ↗