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Steroids In Eosinophil Negative Asthma (SIENA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT02066298
First received: February 10, 2014
Last updated: July 25, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Mometasone 220mcg BID Drug: Tiotropium Respimat 5mcg QD Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Steroids In Eosinophil Negative Asthma

Resource links provided by NLM:


Further study details as provided by dave mauger, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 295
Study Start Date: July 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover sequence 1
Mometasone 220mcg BID, followed by Titropium Respimat 5mcg QD, followed by Placebo
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 2
Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD
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 3
Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD
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 4
Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID
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 5
Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID
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 6
Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Name: Asmanex
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo

Detailed Description:
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).
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066298

  Show 25 Study Locations
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: William Busse, M.D. University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02066298     History of Changes
Other Study ID Numbers: AsthmaNet 007
1U10HL098115 ( U.S. NIH Grant/Contract )
Study First Received: February 10, 2014
Last Updated: July 25, 2017

Keywords provided by dave mauger, Milton S. Hershey Medical Center:
Asthma
Mometasone
Tiotropium

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tiotropium Bromide
Mometasone Furoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 23, 2017