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

Primary Purpose

Asthma

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

fluticasone

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Bone markers after 3 months of fluticasone

Secondary Outcome Measures

Skin thickness measured by ultrasound biomicroscopy

Full Information

NCT ID

NCT00409630

First Posted

December 8, 2006

Last Updated

April 11, 2012

Sponsor

University of Kansas

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00409630

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decided against going forward with the study.

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

University of Kansas

Collaborators

Sanofi

4. Oversight

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

fluticasone

Primary Outcome Measure Information:

Title

Bone markers after 3 months of fluticasone

Secondary Outcome Measure Information:

Title

Skin thickness measured by ultrasound biomicroscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leland Graves, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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