Who is sponsoring NCT01397890?

NCT01397890 is sponsored by AstraZeneca.

What drugs are being tested in NCT01397890?

Interventions in NCT01397890: Budesonide/formoterol (Symbicort® Turbuhaler®), Tiotropium (SpirivaTM).

What condition does NCT01397890 study?

NCT01397890 studies Chronic Obstructive Pulmonary Disease (COPD).

Is NCT01397890 still recruiting?

NCT01397890 is currently completed. Last updated 25 March 2015.

Are results published for NCT01397890?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-03-25 · How we verify

NCT01397890: SECURE 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort® Turbuhaler® 160/4.5μg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 μg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 μg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed Phase 4 Results posted Last updated 25 March 2015

What this trial tests

Phase 4 trial testing Budesonide/formoterol (Symbicort® Turbuhaler®) in Chronic Obstructive Pulmonary Disease (COPD) in 793 participants. Completed in 1 June 2013.

Timeline

1 July 2011

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	793
Start date	1 July 2011
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	31 locations across China, Hong Kong, Indonesia, South Korea, Thailand

Drugs / interventions tested

Budesonide/formoterol (Symbicort® Turbuhaler®)
Tiotropium (SpirivaTM) — full drug profile →

Conditions studied

Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

AstraZeneca — full company profile →

Who can join

40 and older, any sex, with Chronic Obstructive Pulmonary Disease (COPD). 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.

Pre-dose FEV1
Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value

Sponsor's own description

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia.
Lee SD, Xie CM, Yunus F, Itoh Y, et al · · 2016 · cited 38× · PMID 26394882 · DOI 10.1111/resp.12646
Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol Fumarate versus Other Triple Combinations in COPD: A Systematic Literature Review and Network Meta-analysis.
Bourdin A, Molinari N, Ferguson GT, Singh B, et al · · 2021 · cited 21× · PMID 33929661 · DOI 10.1007/s12325-021-01703-z
Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease.
Welsh EJ, Cates CJ, Poole P. · · 2013 · cited 20× · PMID 23728670 · DOI 10.1002/14651858.cd007891.pub3
Comparisons of Efficacy and Safety between Triple (Inhaled Corticosteroid/Long-Acting Muscarinic Antagonist/Long-Acting Beta-Agonist) Therapies in Chronic Obstructive Pulmonary Disease: Systematic Review and Bayesian Network Meta-Analysis.
Lee HW, Kim HJ, Jang EJ, Lee CH. · · 2021 · cited 19× · PMID 33971649 · DOI 10.1159/000515133
Efficacy of ICS versus Non-ICS Combination Therapy in COPD: A Meta-Analysis of Randomised Controlled Trials.
Ding Y, Sun L, Wang Y, Zhang J, et al · · 2022 · cited 7× · PMID 35547781 · DOI 10.2147/copd.s347588
Eligibility of patients with chronic obstructive pulmonary disease for inclusion in randomised control trials investigating triple therapy: a study using routinely collected data.
Whittaker HR, Torkpour A, Quint J. · · 2024 · cited 4× · PMID 38238769 · DOI 10.1186/s12931-024-02672-x
Different inhaled corticosteroid doses in triple therapy for chronic obstructive pulmonary disease: systematic review and Bayesian network meta-analysis.
Lee HW, Park HM, Jang EJ, Lee CH. · · 2022 · cited 4× · PMID 36127353 · DOI 10.1038/s41598-022-18353-y

Verify or expand the search:

Other recruiting trials for Chronic Obstructive Pulmonary Disease (COPD)

Currently open trials in the same condition.

NCT07451977 — Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia · NA · recruiting
NCT07355868 — Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy · EARLY_PHASE1 · recruiting
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NCT07477600 — cfMSC Stem Cell Therapy Targeting COPD · Phase 1, PHASE2 · recruiting
NCT07519603 — Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program · NA · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01397890 (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 AstraZeneca
Last refreshed: 25 March 2015

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/NCT01397890.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing