Phase 3
N=295
Steroids In Eosinophil Negative Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02066298 ↗Enrolled (actual)
295
Serious AEs
1.0%
Results posted
Apr 2019
Primary outcome: Primary: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. — 74; 35; 56; 12 Participants — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mometasone 220mcg BID (Drug); Tiotropium Respimat 5mcg QD (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. |
74; 35; 56; 12; 46; 20 | 0.14 |
| SECONDARY Treatment Failure |
29; 29; 35 | — |
| SECONDARY Annualized Asthma Control Days |
179; 186; 176 | — |
| SECONDARY Forced Expiratory Volume at One Second (FEV1) Percent of Predicted |
92; 94; 95 | — |
| SECONDARY Peak Expiratory Flow Rate |
476; 485; 497 | — |
| SECONDARY Asthma Exacerbations |
1; 3; 5 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02066298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.