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BDP/FF + Tiotropium
BDP/FF + Tiotropium is a Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist combination Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 3 development for Asthma (maintenance therapy), Chronic obstructive pulmonary disease (COPD). Also known as: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d..
BDP/FF (beclomethasone/formoterol) is an inhaled corticosteroid plus long-acting beta-2 agonist combination that reduces airway inflammation and bronchospasm, while tiotropium is a long-acting muscarinic antagonist that provides sustained bronchodilation.
BDP/FF (beclomethasone/formoterol) is an inhaled corticosteroid plus long-acting beta-2 agonist combination that reduces airway inflammation and bronchospasm, while tiotropium is a long-acting muscarinic antagonist that provides sustained bronchodilation. Used for Asthma (maintenance therapy), Chronic obstructive pulmonary disease (COPD).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BDP/FF + Tiotropium |
|---|---|
| Also known as | Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d. |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist combination |
| Target | Glucocorticoid receptor, beta-2 adrenergic receptor, M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
This triple-therapy combination targets multiple pathways in obstructive airway disease. BDP/FF addresses inflammation via the corticosteroid and provides rapid bronchodilation through the beta-2 agonist, while tiotropium adds sustained anticholinergic bronchodilation by blocking M3 muscarinic receptors on airway smooth muscle. Together, they provide complementary anti-inflammatory and bronchodilatory effects for improved lung function and symptom control.
Approved indications
- Asthma (maintenance therapy)
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Throat irritation
- Candidiasis (oral)
Key clinical trials
- Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease (PHASE3)
- TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER) (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:
- BDP/FF + Tiotropium CI brief — competitive landscape report
- BDP/FF + Tiotropium updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about BDP/FF + Tiotropium
What is BDP/FF + Tiotropium?
How does BDP/FF + Tiotropium work?
What is BDP/FF + Tiotropium used for?
Who makes BDP/FF + Tiotropium?
Is BDP/FF + Tiotropium also known as anything else?
What drug class is BDP/FF + Tiotropium in?
What development phase is BDP/FF + Tiotropium in?
What are the side effects of BDP/FF + Tiotropium?
What does BDP/FF + Tiotropium target?
Related
- Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist combination drugs
- Target: All drugs targeting Glucocorticoid receptor, beta-2 adrenergic receptor, M3 muscarinic receptor
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma (maintenance therapy)
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Also known as: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing