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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01019694
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : May 1, 2012
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Combivent CFC-MDI Drug: Combivent Respimat 20/100 mcg Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease
Study Start Date : November 2009
Actual Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Combivent Respimat 20/100 microgram(mcg)
patient to take 1 inhalation 4 times a day
 Drug: Combivent Respimat 20/100 mcg
Open label randomized parallel
Active Comparator: Combivent CFC-MDI 36/206 microgram-mcg
patient to take 2 inhalations 4 times a day
 Drug: Combivent CFC-MDI
36/206 mcg Four times a day (QID)
Active Comparator: Atrovent HFA 42 mcg + Albuterol HFA
patient to take 2 inhalations of each 4 times a day
 Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
Open label randomized parallel


Outcome Measures
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Primary Outcome Measures :
  1. Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [ Time Frame: 48 weeks ]
    Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).


Secondary Outcome Measures :
  1. Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [ Time Frame: 3 weeks ]
    Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).

  2. Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [ Time Frame: 12 weeks ]
    Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).

  3. Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [ Time Frame: 24 weeks ]
    Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).

  4. Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [ Time Frame: 36 weeks ]
    Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).

  5. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 [ Time Frame: 0 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  6. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 [ Time Frame: 3 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  7. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 [ Time Frame: 12 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  8. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 [ Time Frame: 24 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  9. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 [ Time Frame: 36 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  10. Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 [ Time Frame: 48 weeks ]
    Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).

  11. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 [ Time Frame: 0 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  12. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 [ Time Frame: 3 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  13. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 [ Time Frame: 12 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  14. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 [ Time Frame: 24 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  15. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 [ Time Frame: 36 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  16. Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 [ Time Frame: 48 weeks ]
    CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).

  17. Physician's Global Evaluation at Week 0 [ Time Frame: 0 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  18. Physician's Global Evaluation at Week 3 [ Time Frame: 3 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  19. Physician's Global Evaluation at Week 12 [ Time Frame: 12 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  20. Physician's Global Evaluation at Week 24 [ Time Frame: 24 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  21. Physician's Global Evaluation at Week 36 [ Time Frame: 36 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  22. Physician's Global Evaluation at Week 48 [ Time Frame: 48 weeks ]
    Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).

  23. Change From Baseline in FEV1 at Day 1 [ Time Frame: baseline, day 1 ]
    Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.

  24. Change From Baseline in FEV1 at Week 12 [ Time Frame: baseline, 12 weeks ]
    Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12

  25. Change From Baseline in FEV1 at Week 24 [ Time Frame: baseline, 24 weeks ]
    Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24

  26. Change From Baseline in FEV1 at Week 48 [ Time Frame: baseline, 48 weeks ]
    Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48

  27. Change From Baseline in FVC at Day 1 [ Time Frame: baseline, day 1 ]
    Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.

  28. Change From Baseline in FVC at Week 12 [ Time Frame: baseline, 12 weeks ]
    Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12

  29. Change From Baseline in FVC at Week 24 [ Time Frame: baseline, 24 weeks ]
    Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24

  30. Change From Baseline in FVC at Week 48 [ Time Frame: baseline, 48 weeks ]
    Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48

  31. Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 [ Time Frame: 0 weeks ]
    Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0

  32. 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 (albuterol use per 24 hour period) in two weeks prior to week 3

  33. 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 (albuterol use per 24 hour period) in two weeks prior to week 12

  34. 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 (albuterol use per 24 hour period) in two weeks prior to week 24

  35. 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 (albuterol use per 24 hour period) in two weeks prior to week 36

  36. Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 [ Time Frame: 48 weeks ]
    Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48

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

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019694


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01019694    
Other Study ID Numbers: 1012.62
First Posted: November 25, 2009    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: October 23, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Ipratropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents