Last reviewed · How we verify
NCT00929851
a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease
Phase 3 trial testing CHF1535 in Pulmonary Disease, Chronic Obstructive in 1,199 participants. Completed in 1 July 2012.
1 March 2012
Quick facts
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,199 |
| Start date | 1 October 2009 |
| Primary completion | 1 March 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- CHF1535 — full drug profile →
- Formoterol fumarate — full drug profile →
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
Sponsor
Chiesi Farmaceutici S.p.A. — full company profile →
Who can join
40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Exacerbation rate Change in pre-dose FEV1
Time frame: 0-4-12-24-36-48 weeks
Sponsor's own description
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive pulmonary disease (COPD): a systematic review and network meta-analysis.
Oba Y, Keeney E, Ghatehorde N, Dias S. · · 2018 · cited 67× · PMID 30521694 · DOI 10.1002/14651858.cd012620.pub2 -
Targeting Chronic Obstructive Pulmonary Disease Phenotypes, Endotypes, and Biomarkers.
Garudadri S, Woodruff PG. · · 2018 · cited 50× · PMID 30758998 · DOI 10.1513/annalsats.201808-533mg -
Blood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids.
Siddiqui SH, Pavord ID, Barnes NC, Guasconi A, et al · · 2018 · cited 25× · PMID 30464449 · DOI 10.2147/copd.s179425 -
Formoterol for the Treatment of Chronic Obstructive Pulmonary Disease.
Tashkin DP. · · 2020 · cited 10× · PMID 33273813 · DOI 10.2147/copd.s273497 -
The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study.
Singh D, Vezzoli S, Petruzzelli S, Papi A. · · 2017 · cited 2× · PMID 29138555 · DOI 10.2147/copd.s141416
Verify or expand the search:
- PubMed search for NCT00929851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CHF1535
Trials testing the same drug.
- NCT05097014 — CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD · Phase 4 · completed
Other recruiting trials for Pulmonary Disease, Chronic Obstructive
Currently open trials in the same condition.
- NCT07177339 — eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (CO · Phase 3 · recruiting
- NCT06961214 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T · Phase 3 · recruiting
- NCT06959095 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T · Phase 3 · recruiting
- NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
- NCT06712563 — Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting · recruiting
Other Chiesi Farmaceutici S.p.A. trials
Trials by the same sponsor.
- NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
- NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
- NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
- NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
- NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00929851 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A.
- Last refreshed: 28 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00929851.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing