Steroids In Eosinophil Negative Asthma

Asthma Clinical Trial

— SIENA  

Official title:

Steroids In Eosinophil Negative Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066298
• Other study ID #: AsthmaNet 007
• Secondary ID: 1U10HL098115
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: May 2018

Study information

• Verified date: May 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mometasone 220mcg BID
Mometasone is an ICS
• Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
• Placebo

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital, Case Western Reserve University	Cleveland	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Nemours Children's Clinic	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	University of California at San Francisco	San Francisco	California
United States	University of Arizona College of Medicine	Tucson	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.	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.	End of 12-week treatment period
Secondary	Treatment Failure	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	End of 12-week treatment period
Secondary	Annualized Asthma Control Days	Asthma Control Days (ACD) 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. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365.	End of 12-week treatment period
Secondary	Forced Expiratory Volume at One Second (FEV1) Percent of Predicted	FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height.	End of 12-week treatment period
Secondary	Peak Expiratory Flow Rate	Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways.	End of 12-week treatment period
Secondary	Asthma Exacerbations	Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following: FEV1 <50% of baseline on 2 consecutive measurements; FEV1 <40% of predicted on 2 consecutive measurements; Use of = 16 puffs of "as needed" ß-agonist per 24 hours for a period of 48 hours; Use of oral/parenteral corticosteroid due to asthma	End of 12-week treatment period

External Links

•   AsthmaNet