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SPIRIVA in Ususal Care

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ClinicalTrials.gov Identifier: NCT00274079
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:

The objective of the study is to determine the effect on lung function when either SPIRIVA once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve to anticholinergic agents managed in primary care. Previous studies have been in both hospital in and outpatients, with washout of some respiratory medications, this is the first study to be conducted in General Practice, the drug's anticipated environment.

Data from this study, including the adverse event monitoring, and post study findings on physical examination, will be used to extend the safety database. Health Resource Utilisation (HRU) data will be recorded to be use with data from other sources for economic analysis of COPD treatment.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: SPIRIVA Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group, 12 Week Study, Comparing the Effect of Once Daily Tiotropium Lactose Capsule With Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD), naïve to Anticholinergic Agents in Addition to Receiving Their Usual COPD Care
Study Start Date : October 2002
Actual Primary Completion Date : October 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Trough FEV1 response after 2 and 6 weeks [ Time Frame: week 2, week 6 ]
  2. Trough Forced Vital Capacity (FVC) response after 2, 6 and 12 weeks [ Time Frame: week 2, week 6, week 12 ]
  3. Dyspnoea measured by the Oxygen Cost Diagram (OCD [ Time Frame: week 12 ]
  4. Weekly mean number per day of occasions when Short Acting β2 Agonist (SABA) therapy was used [ Time Frame: week 12 ]
  5. Percentage compliance with study medication as assessed by inhalation capsule counts [ Time Frame: week 12 ]
  6. Adverse events [ Time Frame: week 12 ]
  7. Seated pulse rate and blood pressure [ Time Frame: week 12 ]
  8. Physical examination [ Time Frame: week 12 ]

Eligibility Criteria
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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:

  • Prior to participation in the study all patients must sign and date an informed consent consistent with ICH-GCP guidelines.
  • Male or female patients 40 years of age or older.
  • Patients with a diagnosis of COPD according to BTS criteria..A stable disease state with airway obstruction of FEV1 between 30- 65% of predicted normal value and FEV1 /FVC<70% pre bronchodilators.
  • Predicted normal values will be calculated according to ECCS:

  • For height measured in metres

    • Males: FEV1 predicted (L) = 4.30 X (Ht in mts) - 0.029 X (Age in yrs) - 2.49
    • Females:FEV1 predicted (L) = 3.95 X (Ht in mts) - 0.025 X (Age in yrs) - 2.60

  • For height measured in inches

    • Males: FEV1 predicted (L) = 4.30 X (Ht in inches/39.37) - 0.029 X (Age in yrs) - 2.49
    • Females:FEV1 predicted (L) = 3.95 X (Ht in inches/39.37) - 0.025 X (Age in yrs) - 2.60
  • Maintained on a stable respiratory medication for 4 weeks prior to visit 1 (no changes in respiratory medication oral dosage).
  • Currently taking salbutamol or terbutaline MDI or DPI.
  • Patient must be able to inhale medication through the HandiHaler?
  • Patients must be able to perform technically acceptable pulmonary function tests in accordance with ATS criteria and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol.
  • Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
  • Pack Years = Number of cigarettes/day 20 (Patients who have never smoked cigarettes must be excluded.)

NOTE: An exacerbation of COPD requiring treatment occurring within the four week period prior to screening visit 1 will mean that screening should be postponed for at least four weeks. Therefore, the patient should have duration of at least 4 weeks free of exacerbations.

Exclusion Criteria:

  • 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.
  • Patients who have taken inhaled anticholinergics in the previous 12 months. Patients that have been treated with inhaled anticholinergics (via nebuliser or metered dose inhaler) due to an exacerbation for a time period no longer than 7 days may be included.
  • Patients with an upper respiratory tract infection or exacerbation of COPD requiring treatment in the four weeks prior to the screening visit (visit 1) or during the two-week run-in period.

Patients with a recent history (i.e., six months or less) of myocardial infarction.

  • Any unstable or life threatening cardiac arrhythmia requiring intervention or a change in drug therapy within the last year.
  • Patients with known active tuberculosis.
  • Patients who have a history of thoracotomy with pulmonary resection or have planned lung transplantation or lung volume reduction surgery.
  • Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
  • Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions.
  • Patients with a history of cancer in the last five years; Basal cell tumours or patients whose length of time in remission is greater than five years can be included.
  • Patient with known hypersensitivity to atropine, and other anticholinergic drugs or lactose or any previous adverse reaction to anticholinergic drugs that resulted in withdrawal of the anticholinergic compound.
  • Patients using oral corticosteroid medication at unstable doses (i.e. Patients have been on a stable dose for less than 6 weeks prior to randomisation) or at doses in excess of the equivalent of 10mg o
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): NCT00274079


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
More Information
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Additional Information:

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

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ClinicalTrials.gov Identifier: NCT00274079    
Other Study ID Numbers: 205.276
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action