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Bronchodilator

Tiotropium/Salmeterol quaque die (QD, once daily) for Asthma

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosis of COPD
* Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

Summary

The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.

Eligible Conditions
  • Asthma
  • Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Tiotropium/Salmeterol quaque die (QD, once daily)Experimental Treatment1 Intervention
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Group II: Salmeterol bis in die (BID, twice daily)Active Control1 Intervention
Salmeterol Inhalation Powder, hard PE capsule
Group III: Tiotropium quaque die (QD, once daily)Active Control1 Intervention
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Group IV: Tiotropium/Salmeterol quaque die (QD, once daily)+ SalmeterolActive Control1 Intervention
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Group V: PlaceboPlacebo Group1 Intervention
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,857,906 Total Patients Enrolled
67 Trials studying Asthma
140,214 Patients Enrolled for Asthma
~13 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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