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Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD

NCT ID: NCT00662792

Last Updated: 2022-06-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-15

Study Completion Date

2009-07-22

Brief Summary

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The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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T+S_PE/ Tio18GEL / Salm50DPI / T18GEL+S_DPI

7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)/ 18 µg Tiotropium (Tio18GEL) / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (T18GEL) plus 50 µg Salmeterol MDPI (S\_DPI) BID

Group Type EXPERIMENTAL

Tiotropium (Tio18GEL)

Intervention Type DRUG

18 µg Tiotropium (Tio18GEL) inhalation powder

Salmeterol MDPI (Salm50DPI)

Intervention Type DRUG

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

Intervention Type DRUG

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

Tiotropium/Salmeterol (T+S_PE)

Intervention Type DRUG

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Tio18GEL/ T18GEL+S_DPI/ T+S_PE/ Salm50DPI

18 µg Tiotropium (Tio18GEL) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 50 µg Salmeterol MDPI (Salm50DPI)

Group Type EXPERIMENTAL

Tiotropium (Tio18GEL)

Intervention Type DRUG

18 µg Tiotropium (Tio18GEL) inhalation powder

Salmeterol MDPI (Salm50DPI)

Intervention Type DRUG

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

Intervention Type DRUG

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

Tiotropium/Salmeterol (T+S_PE)

Intervention Type DRUG

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Salm50DPI/ T+S_PE/ T18GEL+S_DPI/ Tio18GEL

50 µg Salmeterol MDPI (Salm50DPI) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 18 µg Tiotropium (Tio18GEL)

Group Type EXPERIMENTAL

Tiotropium (Tio18GEL)

Intervention Type DRUG

18 µg Tiotropium (Tio18GEL) inhalation powder

Salmeterol MDPI (Salm50DPI)

Intervention Type DRUG

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

Intervention Type DRUG

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

Tiotropium/Salmeterol (T+S_PE)

Intervention Type DRUG

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

T18GEL+S_DPI/ Salm50DPI/ Tio18GEL/ T+S_PE

18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (Tio18GEL) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)

Group Type EXPERIMENTAL

Tiotropium (Tio18GEL)

Intervention Type DRUG

18 µg Tiotropium (Tio18GEL) inhalation powder

Salmeterol MDPI (Salm50DPI)

Intervention Type DRUG

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

Intervention Type DRUG

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

Tiotropium/Salmeterol (T+S_PE)

Intervention Type DRUG

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Interventions

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Tiotropium (Tio18GEL)

18 µg Tiotropium (Tio18GEL) inhalation powder

Intervention Type DRUG

Salmeterol MDPI (Salm50DPI)

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

Intervention Type DRUG

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

Intervention Type DRUG

Tiotropium/Salmeterol (T+S_PE)

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
2. All patients must have a diagnosis of COPD and must meet the following criteria:

relatively stable\* airway obstruction with a post-bronchodilator FEV1 \< 80% of predicted normal and post-bronchodilator FEV1 \< 70% of post-bronchodilator FVC at Visit 1 (according to GOLD criteria).

\* The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation. Predicted normal values will be calculated according to ECSC.
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of 10 pack-years.
5. Patients must be able to perform technically acceptable pulmonary function tests
6. Patients must be able to inhale medication in a competent manner.
7. Patients must be able to perform all necessary recordings in the diary.

Exclusion Criteria

1. Significant diseases other than COPD
2. Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
5. Hospitalisation for cardiac failure during the past year.
6. Malignancy within the last five years excluded basal cell carcinoma.
7. Patients with a history of asthma or who have a total blood eosinophil count 600/mm3.
8. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
9. Known active tuberculosis.
10. Patients with a history of alcohol or drug abuse.
11. Thoracotomy with pulmonary resection.
12. Rehabilitation program within the last six weeks
13. Patients who regularly use daytime oxygen therapy
14. Patients who have taken an investigational drug within 30 days
15. Use of not allowed medications
16. Known hypersensitivity to used drugs or other components of the study medication.
17. Pregnant or nursing women
18. Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
19. Patients who are currently participating in another study.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1184.13.1302 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.13.1309 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.13.1308 Boehringer Ingelheim Investigational Site

Cottbus, , Germany

Site Status

1184.13.1311 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1184.13.1312 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1184.13.1305 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1184.13.1301 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1184.13.1306 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

Site Status

1184.13.1310 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1184.13.1307 Boehringer Ingelheim Investigational Site

Schwerin, , Germany

Site Status

1184.13.1304 Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

1184.13.1303 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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1184.13

Identifier Type: -

Identifier Source: org_study_id

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