AsthmaNCT00409630
Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
A study testing fluticasone in people with Asthma, run by University of Kansas.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- fluticasone
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- fluticasone
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone markers after 3 months of fluticasone
Secondary outcomes (1)
Skin thickness measured by ultrasound biomicroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
Why it stopped: Sponsor decided against going forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Leland Graves, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409630
- Sponsor's protocol ID
- 10384
- Status last verified
- Apr 2012
- First submitted
- 8 Dec 2006
- Last updated
- 12 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00409630
- Acronym / sponsor ID
- 10384
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided against going forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Sanofi
- First posted
- 11 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Ambulatory status
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone | Drug | – |
Primary outcome
Bone markers after 3 months of fluticasone
1 secondary outcome
Skin thickness measured by ultrasound biomicroscopy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leland Graves, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing fluticasone in people with Asthma, run by University of Kansas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone markers after 3 months of fluticasone. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.