Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT01019694
• Date of registration: 16/11/2009
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
• Scientific title: Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease
• Date of first enrolment: November 2009
• Target sample size: 470
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01019694
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

1. All patients must sign an informed consent consistent with International Conference
on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation
in the trial.

2. Male or female patients 40 years of age or older.

3. Patients must be current or ex-smokers with a smoking history of 10 pack-years.
(Patients who have never smoked cigarettes must be excluded) Pack Years = Number of
cigarettes/day x years of smoking 20 cigarettes/pack

4. All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
(P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively
stable, moderate to severe airway obstruction with a post-bronchodilator Forced
Expiratory Volume in one second (FEV1) < 80% of predicted normal and FEV1/Forced
Vital Capacity (FVC) < 70%. Spirometry should be done at baseline and approximately
1/2 hour following 4 inhalations of albuterol. Predicted normal values will be
calculated according to European Coal and Steel Community (ECSC), European Community
for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1
predicted (L) = 4.30 x [height (inches) / 39.37]-0.029 x age (yrs) - 2.49 Females:
FEV1 predicted (L) = 3.95 x [height (inches) / 39.37]-0.025 x age (yrs) - 2.60 For
Height measured in meters Males: FEV1 predicted (L) = 4.30 x [height (meters)] -
0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x [height (meters)] -
0.025 x age (years) - 2.60

5. Patients must be able to perform all study related procedures and maintain study
records during the study period as required in the protocol.

6. Patients must be able to inhale medication in a competent manner from the RESPIMAT
inhaler and from a metered dose inhaler (MDI).

Exclusion criteria:

1. Patients with significant diseases other than COPD will be excluded. A significant
disease is defined as a disease which in the opinion of the investigator may either
put the patient at risk because of participation in the study or a disease which may
influence the results of the study or the patient's ability to participate in the
study.

2. Patients with a recent history (i.e., one year or less) of myocardial infarction.

3. Patients who have been hospitalized or being treated for heart failure within the
past year.

4. Patients with clinically unstable or life-threatening cardiac arrhythmia requiring
intervention or change in drug therapy within the past year.

5. Patients with a malignancy for which patient has undergone resection, radiation
therapy or chemotherapy within last five years (patients with fully cured squamous
cell or treated basal cell carcinoma are allowed).

6. Patients with a history of life-threatening pulmonary obstruction, or a history of
cystic fibrosis or clinically evident bronchiectasis.

7. Patients who have undergone thoracotomy with pulmonary resection. Patients with a
history of a thoracotomy for other reasons should be evaluated as per exclusion
criterion No. 1.

8. Patients with a current diagnosis of asthma.

9. Patients with a history of significant alcohol or drug abuse.

10. Patients with known active tuberculosis.

11. Patients using beta blocker medications are excluded. Cardioselective beta blockers
are allowed with caution. Beta blocker eye medications for treatment of non-narrow
angle glaucoma are allowed.

12. Patients who regularly use daytime oxygen therapy for more than 1 hour per day
Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed).

13. Patients using oral corticosteroid medication at a dose in excess of the equivalent
of 10 mg of prednisone per day or 20 mg every other day, except as required for
treatment of exacerbation during the study.

14. Pregnant or nursing women.

15. Women of childbearing potential not using a medically approved means of contraception
(i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with
spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a
medically approved means of contraception. Female patients will be considered to be
of childbearing potential unless surgically sterilized by hysterectomy or bilateral
tubal ligation, or post-menopausal for at least two years.

16. Patients with known hypersensitivity to anticholinergic drugs, any other component of
the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride
(BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol
Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components.

17. Previous participation in this study. (The patient cannot re-enroll into this study.)

18. Patients who are currently participating in another interventional study.

19. Patients who have taken an investigational drug within 1 month or 6 half lives
(whichever is greater) prior to screening.

20. Patients currently in any pulmonary rehabilitation program or scheduled to
participate in any such program during the study period.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg

Drug: Combivent CFC-MDI

Drug: Combivent Respimat 20/100 mcg

Primary Outcome(s)

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [Time Frame: 48 weeks]

Secondary Outcome(s)

Change From Baseline in FEV1 at Day 1 [Time Frame: baseline, day 1]

Change From Baseline in FEV1 at Week 12 [Time Frame: baseline, 12 weeks]

Change From Baseline in FEV1 at Week 24 [Time Frame: baseline, 24 weeks]

Change From Baseline in FEV1 at Week 48 [Time Frame: baseline, 48 weeks]

Change From Baseline in FVC at Day 1 [Time Frame: baseline, day 1]

Change From Baseline in FVC at Week 12 [Time Frame: baseline, 12 weeks]

Change From Baseline in FVC at Week 24 [Time Frame: baseline, 24 weeks]

Change From Baseline in FVC at Week 48 [Time Frame: baseline, 48 weeks]

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 [Time Frame: 12 weeks]

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 [Time Frame: 24 weeks]

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 [Time Frame: 3 weeks]

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 [Time Frame: 36 weeks]

Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 [Time Frame: 48 weeks]

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 [Time Frame: 12 weeks]

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 [Time Frame: 24 weeks]

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 [Time Frame: 3 weeks]

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 [Time Frame: 36 weeks]

Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 [Time Frame: 48 weeks]

Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [Time Frame: 48 weeks]

Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization [Time Frame: 48 weeks]

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [Time Frame: 12 weeks]

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [Time Frame: 24 weeks]

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [Time Frame: 3 weeks]

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [Time Frame: 36 weeks]

Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [Time Frame: 48 weeks]

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [Time Frame: 12 weeks]

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [Time Frame: 24 weeks]

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [Time Frame: 3 weeks]

Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [Time Frame: 36 weeks]

Physician's Global Evaluation at Week 12 [Time Frame: 12 weeks]

Physician's Global Evaluation at Week 24 [Time Frame: 24 weeks]

Physician's Global Evaluation at Week 3 [Time Frame: 3 weeks]

Physician's Global Evaluation at Week 36 [Time Frame: 36 weeks]

Physician's Global Evaluation at Week 48 [Time Frame: 48 weeks]

Secondary ID(s)

1012.62

Source(s) of Monetary Support

Please refer to primary and secondary sponsors