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Steroids In Eosinophil Negative Asthma (SIENA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02066298
First Posted: February 19, 2014
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
February 10, 2014
February 19, 2014
July 26, 2017
July 2014
May 2018   (Final data collection date for primary outcome measure)
The primary outcome is a composite measure that uses treatment failures, asthma control days, and percent predicted FEV1. [ Time Frame: End of 12-week treatment period ]
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Same as current
Complete list of historical versions of study NCT02066298 on ClinicalTrials.gov Archive Site
  • Treatment failure [ Time Frame: End of 12-week treatment period ]

    Treatment Failure includes:

    • Awakening from asthma three or more times in a two-week period or on two consecutive nights, or
    • Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or
    • Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or
    • Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or
    • exercise induces unusual breathlessness
  • Asthma Control Days [ Time Frame: End of 12-week treatment period ]
    Asthma Control Days are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline.
  • Forced Expiratory Volume in one second [ Time Frame: End of 12-week treatment period ]
  • Peak Expiratory Flow rate [ Time Frame: End of 12-week treatment period ]
  • Asthma exacerbations [ Time Frame: End of 12-week treatment period ]
Not Provided
Not Provided
Not Provided
 
Steroids In Eosinophil Negative Asthma
Steroids In Eosinophil Negative Asthma
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Mometasone 220mcg BID
    Mometasone is an ICS
    Other Name: Asmanex
  • Drug: Tiotropium Respimat 5mcg QD
    Tiotropium is a LMA
  • Drug: Placebo
  • Experimental: Crossover sequence 1
    Mometasone 220mcg BID, followed by Titropium Respimat 5mcg QD, followed by Placebo
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
  • Experimental: Crossover sequence 2
    Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
  • Experimental: Crossover sequence 3
    Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
  • Experimental: Crossover sequence 4
    Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
  • Experimental: Crossover sequence 5
    Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
  • Experimental: Crossover sequence 6
    Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo
    Interventions:
    • Drug: Mometasone 220mcg BID
    • Drug: Tiotropium Respimat 5mcg QD
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
295
May 2018
May 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Physician-diagnosed asthma for at least previous 12 months.
  • Able to perform reproducible spirometry.
  • Baseline FEV1≥70% of predicted.
  • Asthma confirmed either by:

    • Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
    • Methacholine PC20 ≤ 16 mg/ml
  • At least 1 of the following indications for chronic controller therapy:

    • Asthma Symptoms > 2 days/week OR
    • Nocturnal Asthma Symptoms > 2 nights/month OR
    • Short-acting beta-agonist use for symptom control > 2 days/week
  • For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
  • Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.

Exclusion Criteria:

  • Chronic inhaled or oral corticosteroid therapy.
  • Use of inhaled or oral corticosteroid therapy within 6 weeks.
  • New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
  • Use of omalizumab within 3 months.
  • History of:

    • bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
    • narrow angle glaucoma
    • significant cardiovascular disorders and arrhythmias
    • life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
  • Respiratory tract infection within past 6 weeks.
  • History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.
  • Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02066298
AsthmaNet 007
1U10HL098115 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
dave mauger, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William Busse, M.D. University of Wisconsin, Madison
Milton S. Hershey Medical Center
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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