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Placebo + Tiotropium
Tiotropium is a long-acting anticholinergic bronchodilator that blocks muscarinic receptors in airway smooth muscle to produce sustained bronchodilation.
Tiotropium is a long-acting anticholinergic bronchodilator that blocks muscarinic receptors in airway smooth muscle to produce sustained bronchodilation. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy, Asthma (in combination with inhaled corticosteroids).
At a glance
| Generic name | Placebo + Tiotropium |
|---|---|
| Also known as | Spiriva |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Drug class | Long-acting muscarinic antagonist (LAMA) |
| Target | M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Tiotropium binds to M3 muscarinic receptors on airway smooth muscle cells, preventing acetylcholine-induced bronchoconstriction. This results in sustained airway relaxation and improved airflow. The placebo control in this formulation is used for comparative efficacy assessment in clinical trials.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Asthma (in combination with inhaled corticosteroids)
Common side effects
- Dry mouth
- Tremor
- Headache
- Urinary retention
- Tachycardia
Key clinical trials
- Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PHASE4)
- A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma (PHASE2)
- Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response (PHASE4)
- Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD (PHASE4)
- Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- 12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD) (PHASE4)
- Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo + Tiotropium CI brief — competitive landscape report
- Placebo + Tiotropium updates RSS · CI watch RSS
- IRCCS Azienda Ospedaliero-Universitaria di Bologna portfolio CI