A full pulmonary function test is required to meet the standard set forth on the insert:
"Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients."
The FDA is simply using "FEV1" as an abbreviation for "pulmonary function test." It is not possible to identify "potential lung disease" without the full complement of tests. This video gives a pretty demonstration of what usually happens:
www.youtube.com/watch?v=1rjN2_hDXEY
And this is the first in a series of videos that explains interpretation of the results:
www.youtube.com/watch?v=S9OWa8ot75o
That might help explain why endos are reluctant to provide spirometry.
Your statement about a full pulmonary function test requirement is a complete falsehood.
A full pulmonary function test includes multiple and varied breathing exercises that record the following measurements:
- Diffusion capacity to carbon monoxide (DLCO)
- Expiratory reserve volume (ERV)
- Forced vital capacity (FVC)
- Forced expiratory volume (FEV)
- Forced expiratory flow 25% to 75%
- Functional residual capacity (FRC)
- Maximum voluntary ventilation (MVV)
- Residual volume (RV)
- Peak expiratory flow (PEF).
- Slow vital capacity (SVC)
- Total lung capacity (TLC)
Of these, only spirometry (FEV1) is specifically mentioned on the FDA-approved label & insert, the most detailed of which is the following:
5 WARNINGS AND PRECAUTIONS
5.1 Acute Bronchospasm in Patients with Chronic Lung Disease
Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung
disease such as asthma or COPD [see Contraindications (4)].
Before initiating therapy with AFREZZA, evaluate all patients with a medical history, physical
examination and spirometry (FEV1) to identify potential underlying lung disease.
Acute bronchospasm has been observed following AFREZZA dosing in patients with asthma and
patients with COPD. In a study of patients with asthma, bronchoconstriction and wheezing following
AFREZZA dosing was reported in 29% (5 out of 17) and 0% (0 out of 13) of patients with and without
a diagnosis of asthma, respectively. In this study, a mean decline in FEV1 of 400 mL was observed
15 minutes after a single dose in patients with asthma. In a study of patients with COPD (n=8), a mean
decline in FEV1 of 200 mL was observed 18 minutes after a single dose of AFREZZA. The long-term
safety and efficacy of AFREZZA in patients with chronic lung disease has not been established.
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5.4 Decline in Pulmonary Function
AFREZZA causes a decline in lung function over time as measured by FEV1. In clinical trials excluding
patients with chronic lung disease and lasting up to 2 years, AFREZZA-treated patients experienced
a small [40 mL (95% CI: -80, -1)] but greater FEV1 decline than comparator-treated patients. The FEV1
decline was noted within the first 3 months, and persisted for the entire duration of therapy (up to 2
years of observation). In this population, the annual rate of FEV1 decline did not appear to worsen with
increased duration of use. The effects of AFREZZA on pulmonary function for treatment duration longer
than 2 years has not been established. There are insufficient data in long term studies to draw
conclusions regarding reversal of the effect on FEV1 after discontinuation of AFREZZA. The observed
changes in FEV1 were similar in patients with type 1 and type 2 diabetes.
Assess pulmonary function (e.g., spirometry) at baseline, after the first 6 months of therapy, and
annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of
>/= 20% in FEV1 from baseline, consider discontinuing AFREZZA. Consider more frequent monitoring
of pulmonary function in patients with pulmonary symptoms such as wheezing, bronchospasm,
breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue AFREZZA. [see
Adverse Reactions (6)].
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FEV1 is the only test required that is printed on the FDA-approved label/insert. This is NOT full pulmonary testing as you stated. The only requirement is for a simple breathing test (spirometry) that measures Forced Expiratory Volume over a 1 second duration, followed by an initial 6-month FEV1 and then another each year. The label also states that Afrezza-treated patients experienced a small decline in lung function over two years.