A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva (R) HandiHaler (R)) 18 µg once daily (EXACTT trial) - EXACTT

• Register: EUCTR
• Last refreshed on: 3 July 2012
• Main ID: EUCTR2006-004610-41-DE
• Date of registration: 02/05/2007
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals Inc.
• Public title: A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva (R) HandiHaler (R)) 18 µg once daily (EXACTT trial) - EXACTT
• Scientific title: A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva (R) HandiHaler (R)) 18 µg once daily (EXACTT trial) - EXACTT
• Date of first enrolment: 13/06/2007
• Target sample size: 460
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004610-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Germany, Italy, Portugal, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female
-40 years old or more
-with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less than predicted, post bronchodilator FEV1 65% or less than predicted, FEV1/FVC less than 70%)
-smoking history 10 or more pack-years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-history of asthma
-use of supplemental oxygen therapy
-recent history of MI
-history of thoracotomy with pulmonary resection
-chronic use of systemic corticosterids in an unstable daily dose (< 6 weeks) or a daily dose of>10 mg of prednisone or equivalent
-BPH or bladder neck obstruction; narrow angle glaucome; moderate to severe renal impairment; active tuberculosis
-BMI < 18 kg/m2 or >35 kg/m


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease

Intervention(s)

Trade Name: Spiriva, 18 µg, inhalation powder, hard capsule
Product Name: Tiotropium / HandiHaler
Product Code: Tiotropium / HandiHaler
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tiotropium bromide
CAS Number: 411207-31-3
Current Sponsor code: BA 679 BR
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): The difference between treatment groups of the exercise duration Constant Work Rate (CWR) treadmill exercise at 96 weeks

Secondary Objective: Secondary endpoints:
-Exercise duration at Visit 11
-FEV1 and FVC measurements at each time point
-Questionnaires: Modified Borg Scale; Global evaluation; SGRQ
-COPD exacerbations
-Exercise duration at visits 4-9

Main Objective: Evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily, in patients with COPD compared to placebo.

Secondary ID(s)

2006-004610-41-ES

205.368