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NCT01694771 · ClinicalTrials.gov registry record · Phase 3

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
1,134
Enrollment target

NCT01694771: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT01694771 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,134 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01694771, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
1,134 participants
Enrollment target

Study Summary

The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Primary Outcome

FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12

Interventions

  • DRUG Tiotropium
  • DRUG Olodaterol
  • DRUG Placebo matching Olodaterol

Trial Details

FieldValue
Enrollment Target 1,134 participants
Start Date 2012-09
Est. Completion 2013-08
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT01694771 record still lists

NCT01694771 is an interventional study that assigns participants to a tested intervention. Its 1,134 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).

The record links to 0 conditions, and to 3 interventions - of which Tiotropium is the first listed.

NCT01694771 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01694771 about?

NCT01694771 is a clinical study titled "Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®". The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) mo...

What is the current status of trial NCT01694771?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,134 participants. The study started on 2012-09. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01694771?

The interventions under investigation include: Tiotropium (DRUG), Olodaterol (DRUG), Placebo matching Olodaterol (DRUG).

Who is sponsoring clinical trial NCT01694771?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01694771's enrollment target sits among peer trials

1,134 244th of 2000 higher than 1,757 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01694771, the US trial registry maintained by the National Library of Medicine. NCT01694771 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.