Phase 3
Completed N=1,070
Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Source: ClinicalTrials.gov NCT01290874 ↗Enrolled (actual)
1,070
Serious AEs
14.3%
Results posted
Mar 2018
Primary outcomePrimary: Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) — 0.37; 0.42 event per person-year — p=0.31
◆ Published Evidence
Established
64citations · ~6 / year
Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial.
Summary
We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.
Linked Publications (2)
-
Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial.
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Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) |
0.37; 0.42 | 0.31 |
| SECONDARY Change in FEV1 |
-0.018; 0.003 | — |
| SECONDARY Change in Asthma Control Questionnaire (ACQ) |
-0.70; -0.66 | — |
| SECONDARY Change in Asthma Quality of Life (AQLQ) |
1.00; 1.02 | — |
| SECONDARY Change in Asthma Symptom Utility Index (ASUI) |
0.11; 0.10 | — |
| SECONDARY Change in Symptom-Free Day Questionnaire (SFDQ) |
— | — |
| SECONDARY Change in Rescue Medication Use |
-0.92; -0.97 | — |
| SECONDARY Change in Moderate Asthma Deterioration |
— | — |
Eligibility Criteria
Inclusion Criteria
- Black (self-identified, with at least one biological parent identified as Black)
- Male and female subjects, ages 18-75
- Ability to provide informed consent
- Clinical history consistent with asthma for > 1 year.
- Ability to perform pulmonary function tests
- FEV1 > 40% of predicted
- Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate dose monotherapy and baseline ACQ>1.25
- Non-smoker for past year (total lifetime smoking history < 10 pack-years)
Exclusion Criteria
- Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily
- Chronic use of oral corticosteroids or Anti IgE for asthma
- Lung disease other than asthma or diagnosis of vocal cord dysfunction.
- Significant medical illness (other than asthma) that is not stable.
- Pregnancy or lactation or an unwillingness to maintain effective birth control.
- History of a significant exacerbation of asthma or respiratory tract infection in the prior 4 weeks
- History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within 5 years.
- Hypo sensitization therapy other than an established maintenance regimen.
- Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month
- Known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy.
- Inability to speak and read English.
Data sourced from ClinicalTrials.gov (NCT01290874) and the linked publication. 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. Informational only — not medical advice.