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NCT01476813
A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
Phase 2 trial testing Glycopyrrolate in Pulmonary Disease, Chronic Obstructive in 281 participants. Completed in 1 July 2013.
1 September 2012
Quick facts
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 281 |
| Start date | 1 March 2012 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 July 2013 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Glycopyrrolate — full drug profile →
- Glycopyrrolate — full drug profile →
- Glycopyrrolate — full drug profile →
- Comparator
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
Adults 40 to 80, 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.
-
Aera under curve FEV1 AUC 0-12h
Time frame: day 1 and 7 of treatment period
Sponsor's own description
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Once daily long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus placebo for chronic obstructive pulmonary disease.
Maqsood U, Ho TN, Palmer K, Eccles FJ, et al · · 2019 · cited 17× · PMID 30839102 · DOI 10.1002/14651858.cd012930.pub2 -
The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study).
Singh D, Schröder-Babo W, Cohuet G, Muraro A, et al · · 2016 · cited 15× · PMID 27109816 · DOI 10.1016/j.rmed.2016.03.018
Verify or expand the search:
- PubMed search for NCT01476813
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Glycopyrrolate
Trials testing the same drug.
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- NCT05693246 — Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia · NA · unknown
- NCT03791801 — The Use of Sugammadex in the Critically Ill · NA · unknown
- NCT03939923 — Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Su · Phase 4 · completed
Other recruiting trials for Pulmonary Disease, Chronic Obstructive
Currently open trials in the same condition.
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- 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 NCT01476813 (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/NCT01476813.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing