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

Phase 3

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium/Salmeterol QD; Drug: Tiotropium/Salmeterol QD+ Salmeterol; Drug: Placebo; Drug: Tiotropium (Spiriva®); Drug: Salmeterol

• Registration Number: NCT00662740
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-15
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Primary Completion: 2008-11-21
• Study Completion: 2008-11-21
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium/Salmeterol quaque die (QD, once daily)	Tiotropium/Salmeterol QD	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Tiotropium/Salmeterol quaque die (QD, once daily)+ Salmeterol	Tiotropium/Salmeterol QD+ Salmeterol	Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Placebo	Placebo	Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Tiotropium quaque die (QD, once daily)	Tiotropium (Spiriva®)	Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Salmeterol bis in die (BID, twice daily)	Salmeterol	Salmeterol Inhalation Powder, hard PE capsule

Primary Outcome Measures

Name	Time	Method
Trough forced expiratory volume in one second (FEV1) response	12 Weeks, 24 Weeks and 48 Weeks
FEV1 area under the curve (AUC) 0-8h response	12 Weeks, 24 Weeks and 48 Weeks
Mahler Transition Dyspnoea Index (TDI) focal score	12 Weeks, 24 Weeks and 48 Weeks
St George Respiratory Questionnaire (SGRQ) total score	12 Weeks, 24 Weeks and 48 Weeks
Time to first moderate to severe COPD exacerbation	12 Weeks, 24 Weeks and 48 Weeks

Secondary Outcome Measures

Name	Time	Method
All adverse events	48 weeks
Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort)	4, 12, 24, 36 and 48 weeks
SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ	4, 12, 36 and 48 weeks
Routine blood chemistry, haematology and urinalysis	Baseline and 48 weeks
FEV1 AUC 0-8h response	4, 36 and 48 weeks
Trough FEV1 response	4, 36 and 48 weeks
Peak FEV1 response	12, 24, 36 and 48 weeks
Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time)	24 hours
Forced vital capacity (FVC) AUC0-8h and trough FVC response	48 weeks
Individual FEV1, FVC and peak expiratory flow (PEF) measurements	48 weeks
Weekly mean morning pre-dose and evening pre-dose PEFs and FEV1 (recorded by Asthma Monitor® 2 (AM2+)); PEFs determined by spirometry ]	48 weeks
Weekly mean number of COPD related night time awakenings	1 week
Vital status of randomised patients	48 weeks
Mahler TDI focal score	4, 36 and 48 weeks
Vital signs: pulse rate and blood pressure	Baseline and 4 weeks
Number of days in hospital (including ambulance transportation	48 weeks
Number of unscheduled health care provider visits	48 weeks
Number of visits in emergency room (including ambulance transportation)	48 weeks
Number of days in intensive care unit	48 weeks
Concomitant medications (for instance antibiotics and systemic steroids).	48 weeks

Trial Locations

Locations (72)

1184.14.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Boulder, Colorado, United States

1184.14.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 Wheat Ridge, Colorado, United States

1184.14.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Winter Park, Florida, United States

1184.14.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Coeur d'Alene, Idaho, United States

1184.14.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 South Bend, Indiana, United States

1184.14.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Lafayette, Louisiana, United States

1184.14.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Bangor, Maine, United States

1184.14.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Edina, Minnesota, United States

1184.14.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Burlington, North Carolina, United States

1184.14.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

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