Vitamin D for the Treatment of Severe Asthma

NCT00712205 | Unknown Phase 4

• 1 other identifier: KSBH-336-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to test the hypothesis, that vitamin D3 improves pulmonary function and quality of life in patients with asthma relatively resistant to glucocorticoids.

Conditions

Asthma

Keywords

Asthma; Vitamin D

Outcome Measures

Primary Outcomes (1)

• the area under the 12-hour serial FEV1 curve relative to day-1 baseline (FEV1 AUCbl) and bronchial responsiveness to methacholine

  4 weeks

Secondary Outcomes (1)

• daily morning and evening PEF, daily patient-rated asthma symptom scores, short-acting betamimetics use, nighttime awakenings due to asthma requiring short-acting betamimetics use and the fraction of the exhaled nitric oxide (FENO).

  daily

Study Arms (2)

A

PLACEBO COMPARATOR

20 Patients with asthma in a crossover design

Drug: Placebo

B

ACTIVE COMPARATOR

20 Patients with asthma in a crossover design

Drug: Placebo; Drug: Calcitriol

Interventions

Placebo DRUG

once daily 1mcg Placebo for 28days followed by crossover treatment

A; B

Calcitriol DRUG

once daily 1mcg Calcitriol / Placebo for 28days followed by crossover treatment

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients of either sex,
• ages ≥18 years, with a history of persistent asthma as defined by the American Thoracic Society (ATS) will be eligible for entry into the study.
• Additionally, patients must have been previously treated with ICS for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
• Patients will be required to have a forced expiratory volume in 1 s (FEV1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
• an improvement in FEV1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
• airway hyperresponsiveness to methacholine causing a 20% decline in FEV1 (PC20 FEV1) at a concentration of \< 16 mg/ml;
• diurnal peak expiratory flow (PEF) variability of ≥ 15% during at least 3 of 7 days before randomization.

You may not qualify if:

• Patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
• Also patients will not be eligible if they had \> 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required \> or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
• Patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-IgE (Xolair®).
• Patients with chronic obstructive pulmonary disease and current or former smokers of \>10 pack-years

Sponsors & Collaborators

• Kantonsspital Baselland Bruderholz: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Department of Medicine

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

Related Publications (1)

• Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.

  PMID: 21060320 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Albrecht Breitenbuecher, MD

  Kantonsspital Baselland Bruderholz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: July 9, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 13, 2009

Record last verified: 2009-08

Locations

CH (1)