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Double-Duty inhaler aims to ease breathing in COPD

NCT ID NCT00668772

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a fixed-dose combination inhaler containing tiotropium and salmeterol works better than either drug alone or placebo for people with chronic obstructive pulmonary disease (COPD). The study measures improvements in lung function, shortness of breath, and quality of life over 12 to 24 weeks. Participants are randomly assigned to receive the combination, one of the individual drugs, or a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a fixed-dose combination of tiotropium and salmeterol inhaled as a powder
What this could lead to
If successful, this combination inhaler could offer better symptom control and fewer flare-ups for people with COPD.
What could go wrong
This is a relatively small trial, and the benefits seen may not apply to all COPD patients. The combination also carries risks like increased heart rate or tremor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

207 people

The number who actually took part.

Started

Apr 2008

Finished

Nov 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Main: * Diagnosis of chronic obstructive pulmonary disease (COPD) * Post-bronchodilator forced expiratory volume in one second (FEV1) \<80% predicted and FEV1/forced vital capacity (FVC) \<70% predicted Exclusion criteria: Main: * Significant other diseases then COPD * Recent myocardial infarction (MI) * Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year * Hospitalisation for cardiac failure during the past year * History of asthma

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary disease, chronic obstructive

Contacts and locations

Locations

  • 1184.15.01051 Boehringer Ingelheim Investigational Site

    Morgantown, West Virginia, United States

  • 1184.15.01052 Boehringer Ingelheim Investigational Site

    New Orleans, Louisiana, United States

  • 1184.15.01053 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico, United States

  • 1184.15.01054 Boehringer Ingelheim Investigational Site

    Clearwater, Florida, United States

  • 1184.15.01055 Boehringer Ingelheim Investigational Site

    St Louis, Missouri, United States

  • 1184.15.01057 Boehringer Ingelheim Investigational Site

    Elizabeth City, North Carolina, United States

  • 1184.15.01058 Boehringer Ingelheim Investigational Site

    St Louis, Missouri, United States

  • 1184.15.01059 Boehringer Ingelheim Investigational Site

    Charleston, South Carolina, United States

  • 1184.15.01062 Boehringer Ingelheim Investigational Site

    St Louis, Missouri, United States

  • 1184.15.01063 Boehringer Ingelheim Investigational Site

    Tampa, Florida, United States

  • 1184.15.01064 Boehringer Ingelheim Investigational Site

    Tampa, Florida, United States

  • 1184.15.01065 Boehringer Ingelheim Investigational Site

    Savannah, Georgia, United States

  • 1184.15.01069 Boehringer Ingelheim Investigational Site

    Anniston, Alabama, United States

  • 1184.15.01070 Boehringer Ingelheim Investigational Site

    New York, New York, United States

  • 1184.15.01071 Boehringer Ingelheim Investigational Site

    Mobile, Alabama, United States

  • 1184.15.01072 Boehringer Ingelheim Investigational Site

    Summit, New Jersey, United States

  • 1184.15.02051 Boehringer Ingelheim Investigational Site

    Scarborough Village, Ontario, Canada

  • 1184.15.02053 Boehringer Ingelheim Investigational Site

    Toronto, Ontario, Canada

  • 1184.15.02055 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario, Canada

  • 1184.15.02056 Boehringer Ingelheim Investigational Site

    Montreal, Quebec, Canada

  • 1184.15.02057 Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, Canada

  • 1184.15.02058 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario, Canada

  • 1184.15.02059 Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, Canada

  • 1184.15.02060 Boehringer Ingelheim Investigational Site

    Longueuil, Quebec, Canada

  • 1184.15.27051

    Bellville, South Africa

  • 1184.15.27052

    Cape Town, South Africa

  • 1184.15.27053

    Somerset West, South Africa

  • 1184.15.31051 Boehringer Ingelheim Investigational Site

    Breda, Netherlands

  • 1184.15.31052 Boehringer Ingelheim Investigational Site

    Zutphen, Netherlands

  • 1184.15.31054 Boehringer Ingelheim Investigational Site

    Utrecht, Netherlands

  • 1184.15.3350A Boehringer Ingelheim Investigational Site

    Marseille, France

  • 1184.15.3351A Boehringer Ingelheim Investigational Site

    Nantes, France

  • 1184.15.3352A Boehringer Ingelheim Investigational Site

    Paris, France

  • 1184.15.35851 Boehringer Ingelheim Investigational Site

    Tampere, Finland

  • 1184.15.35852 Boehringer Ingelheim Investigational Site

    Oulu, Finland

  • 1184.15.36052 Boehringer Ingelheim Investigational Site

    Szeged, Hungary

  • 1184.15.36053 Boehringer Ingelheim Investigational Site

    Érd, Hungary

  • 1184.15.36054 Boehringer Ingelheim Investigational Site

    Szarvas, Hungary

  • 1184.15.36055 Boehringer Ingelheim Investigational Site

    Deszk, Hungary

  • 1184.15.37053 Boehringer Ingelheim Investigational Site

    Klaipėda, Lithuania

  • 1184.15.37152 Boehringer Ingelheim Investigational Site

    Jelgava, Latvia

  • 1184.15.37153 Boehringer Ingelheim Investigational Site

    Tukums, Latvia

  • 1184.15.37154 Boehringer Ingelheim Investigational Site

    Balvi, Latvia

  • 1184.15.37251 Boehringer Ingelheim Investigational Site

    Tallinn, Estonia

  • 1184.15.37252 Boehringer Ingelheim Investigational Site

    Kohtla-Järve, Estonia

  • 1184.15.39051 Boehringer Ingelheim Investigational Site

    Florence, Italy

  • 1184.15.42153 Boehringer Ingelheim Investigational Site

    Bratislava, Slovakia

  • 1184.15.42154 Boehringer Ingelheim Investigational Site

    Bratislava, Slovakia

  • 1184.15.43052 Boehringer Ingelheim Investigational Site

    Gänserndorf, Austria

  • 1184.15.43053 Boehringer Ingelheim Investigational Site

    Vienna, Austria

  • 1184.15.45051 Boehringer Ingelheim Investigational Site

    Odense C, Denmark

  • 1184.15.45052 Boehringer Ingelheim Investigational Site

    Kolding, Denmark

  • 1184.15.45053 Boehringer Ingelheim Investigational Site

    Silkeborg, Denmark

  • 1184.15.45054 Boehringer Ingelheim Investigational Site

    Aalborg, Denmark

  • 1184.15.46051 Boehringer Ingelheim Investigational Site

    Stockholm, Sweden

  • 1184.15.46053 Boehringer Ingelheim Investigational Site

    Boden, Sweden

  • 1184.15.49052 Boehringer Ingelheim Investigational Site

    Hanover, Germany

  • 1184.15.49053 Boehringer Ingelheim Investigational Site

    Frankfurt, Germany

  • 1184.15.49056 Boehringer Ingelheim Investigational Site

    Aschaffenburg, Germany

  • 1184.15.49057 Boehringer Ingelheim Investigational Site

    Gelnhausen, Germany

  • 1184.15.49058 Boehringer Ingelheim Investigational Site

    Hanover, Germany

  • 1184.15.82051 Boehringer Ingelheim Investigational Site

    Jeonju, South Korea

  • 1184.15.82052 Boehringer Ingelheim Investigational Site

    Suwon, South Korea

  • 1184.15.82053 Boehringer Ingelheim Investigational Site

    Wŏnju, South Korea

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