Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma

Kansas Board of Regents

Status

Withdrawn

Conditions

Asthma

Treatments

Drug: fluticasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00409630

10384

Details and patient eligibility

About

Subjects between the ages of 20-45 with mild to moderate asthma will be recruited. Following consent, subjects will undergo an evaluation to assure no underlying metabolic bone disease. Individuals will be treated with inhaled fluticasone low or high dose, daily for 3 months. Serum and urine biochemical markers of bone metabolism will be collected at baseline and monthly for three months. Adherence to study medication and adverse events will be collected at monthly intervals. Differences between fluticasone low and high dose treated individuals will be analyzed between groups and compared with baseline values.

Full description

This study will be a prospective randomized trial. Thirty subjects with mild to moderate asthma will receive inhaled fluticasone propionate. Fifteen patients will receive low dose inhaled fluticasone 88 mcg twice daily. Fifteen patients will receive inhaled fluticasone 440 mcg twice daily. The primary outcome will be biochemical markers of bone turnover. These will include 1) serum biochemical markers of bone formation [osteocalcin, bone specific alkaline phosphatase (ALP) and procollagen I C-terminal propeptide (PICP)] and 2) markers of bone resorption, serum collagen type 1 C-Telopeptide (CTx) urinary N-telopeptide (NTx) and immunoreactive free deoxypyridinoline (iFDpd)]. Secondary endpoints will include, parathyroid hormone (PTH), Urinary Calcium/creatinine, and adverse events.

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Before any study-specific procedure, the appropriate informed consent must be signed
Male and premenopausal female subjects
Age ≥ 20 years through ≤ 45 years of age
Documented History of Mild to moderate Asthma as defined by the NHLBI guidelines:
- Mild Intermittent - FEV1 or PEF >/= 80% predicted, PEF variability <20%.
- Mild persistent - FEV1 or PEF >80% predicted, PEF variability, >/= 20-30%
- Moderate persistent - FEV1 or PEF>60%-<80% predicted, PEF variability >30%
Ambulatory status

Exclusion criteria

Smoking
Current use of inhaled glucocorticoid therapy or use within the past 3 months. Current use of leukotriene modifiers and/or inhaled bronchodilators will be allowed.
Use of oral glucocorticoids within the past year.
Pregnant or breast feeding.
Last menstrual period greater than 1 year ago
Diabetes Mellitus type 1 or 2
Paget's Disease, osteomalacia, hyperparathyroidism, renal osteodystrophy or other metabolic bone diseases
History of hyperthyroidism within 1 year of randomization
AST or ALT > 2x upper limit of normal
Serum creatinine greater than 2.0 mg/DL
History of cancer within the previous 5 years, (exceptions: excised superficial lesions, such as basal or squamous cell carcinoma of the skin.
The use of thiazide diuretics or anticonvulsant medications.
Subject is currently enrolled or has received investigational drug within 30 days prior to randomization
Use of (within 3 months of randomization) hormones, SERMS, calcitonin, PTH (Forteo)
Use of (within 6 months of randomization) bisphosphonates, (Fosamax, Actonel, Didronel), Vitamin D 50,000 iu
Use of (within 12 months of randomization) corticosteroids and/or inhaled steroids, anticonvulsants. Topical and intra-articular steroids are allowed except for topical steroids applied to the area where measurements of skin thickness will be made; ie.
Use of (within 24 months of randomization) I.V. Zometa or I.V. Aredia
Subject has any disorder that compromises the ability of the subject to give written consent and/or to comply with study procedures