Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Salmeterol; Drug: Placebo; Drug: Tiotropium (Spiriva®); Drug: Tiotropium/Salmeterol QD; Drug: Tiotropium/Salmeterol QD+ Salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662740

2007-005134-36 (EudraCT Number)

1184.14

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion criteria:

• Diagnosis of COPD
• Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Main Exclusion criteria:

• Significant other diseases then COPD
• Recent myocardial infarction (MI)
• Unstable or life-threatening arrythmia requiring intervention or change in drug therapy
• Hospitalisation for cardiac failure in past year
• History of asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 5 patient groups, including a placebo group

Tiotropium/Salmeterol quaque die (QD, once daily)

Experimental group

Description:

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Treatment:

Drug: Tiotropium/Salmeterol QD

Tiotropium quaque die (QD, once daily)

Active Comparator group

Description:

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Treatment:

Drug: Tiotropium (Spiriva®)

Salmeterol bis in die (BID, twice daily)

Active Comparator group

Description:

Salmeterol Inhalation Powder, hard PE capsule

Treatment:

Drug: Salmeterol

Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol

Active Comparator group

Description:

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Treatment:

Drug: Tiotropium/Salmeterol QD+ Salmeterol

Placebo

Placebo Comparator group

Description:

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Treatment:

Drug: Placebo